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Job Description
As a part of our Global Anti Bribery & Corruption (ABAC) Program (“the Team”), Associate Director, Compliance Data Risk Analytics & Monitoring will have responsibility for the management of the Company’s global compliance risk data monitoring program for certain ex-US regions.
In addition, the Associate Director work with the Team to conduct above-region analytics and monitoring focused on transfer of value compliance risk and other compliance projects. The responsibilities will involve cross-functional interface with region and market functions, including Human Health International, International Commercial Operations, and International Legal & Compliance.
Reporting directly to the Executive Director, Global Anti Bribery & Corruption Program, this position is based out of our Headquarter site in Rahway (NJ) with a hybrid setup (combination of an in-office & remote). This position cannot be 100% remote.
Current Position Responsibilities:
Required Experience and Skills:
Preferred Experience and Skills:
Education:
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
Pay Transparency Nondiscrimination
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.
Expected salary range:
$122,800.00 - $193,300.00Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
HybridShift:
1st - DayValid Driving License:
NoHazardous Material(s):
N/AOfficial account of Jobstore.
Job Description
Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards.
It is business critical that our Company receives consistent, accurate, high-quality data from clinical trials conducted worldwide. In partnership with the Clinical Quality Operations Lead (CQOL) and Head of Clinical Quality Operations, the Clinical Quality Operations Manager (CQOM) is accountable for the execution of operational quality activities within the assigned therapeutic area. This includes operational quality management and inspection management activities. The position will oversee headquarters clinical quality operations and support clinical trial teams within the assigned therapeutic area, to proactively embed quality into our Company sponsored trials, ensure adequate vendor oversight and address any quality issues as needed. The incumbent will be tasked with the development of quality plans to implement `quality by design` within clinical development programs, using a risk-based approach. They will be responsible for the overall strategy for maintaining ongoing inspection readiness as well as preparing for, management and follow up of regulatory inspections.
Primary Duties:
Operational Quality Management:
Overseeing the strategic implementation of `quality by design` principles in assigned clinical trials.
Develop Risk Assessment and Categorization Tools and Quality Plans in partnership with the CTT.
Collectively and periodically (e.g. quarterly) perform a TA-level review of quality plans and risk mitigation approaches in order to identify any emerging signals or trends and provide relevant feedback to the CQOL and Head of CQO as appropriate.
Responsible for ensuring comprehensive oversight of all activities delegated to third parties. This will include, but not be limited to: 1) Facilitating and monitoring CTT oversight of vendors; 2) Development, review and revision of quality agreements with business partners (i.e. co-development of products with other pharmaceutical companies); and 3) Ensuring that essential elements of the quality management system are in place for studies conducted in partnership with non-commercial organizations (e.g. Non-Governmental Organization (NGO), government or academic institutions).
Facilitate and oversee the responses to audit and inspection observations as appropriate. In addition, work with peers to analyze data across therapy areas in order to identify signals and trends and will then develop and implement appropriate process improvement strategies.
In partnership with the CQOL, the CQOM will develop skill sets in order to be able to recognize and appropriately respond to new and emerging risks through the use of technology. In particular this will include developing and maintaining a deep knowledge of Good Clinical Practice (GCP) with respect to digital data management (i.e. use of novel technology within clinical trials).
Build and enable effective working relationships with key stakeholders in order to ensure and maintain role clarity and business effectiveness. This will include ongoing partnership with the Research & Development Division Quality Assurance (QA) and acting as the link between Clinical Development, study teams, global business functions and regional study management.
In collaboration with peers, will contribute to the standardization of Clinical Quality Operations procedures, tools and templates in order to ensure consistency and seamless progression through the study lifecycle.
Inspection Preparation and Management:
Maintain current regulatory inspection knowledge as it relates to Good Clinical Practice (GCP) inspections by regulatory agencies worldwide, especially those conducted by key authorities such as the USA Food and Drug Administration, European Medicines Agency, UK Medicines and Healthcare products Regulatory Agency, as well as other established and emerging authorities.
Lead and support GCP inspections, worldwide. The CQOM may be assigned as Point of Contact (POC) for a specific area of regulations (e.g. FDA, EMA, NMPA, etc.). As such, the COM is responsible for monitoring, interpreting and communicating key regulatory developments within CQO.
Team up with other therapeutically aligned CQOM to provide comprehensive oversight of the TA. Maintain contemporaneous awareness of filing schedules, potential future inspections and ongoing inspection preparation activity.
Develop, update, and maintain GCP inspection procedures and guidelines within Global Clinical Trial Operations (GCTO).
Contribute to the development and/ or revision of our Company policies, SOPs and training materials.
Develop the strategy for management/support for GCP inspections of our Company products to ensure that all phases of Regulatory Health Authority inspections (i.e. inspection preparation, management and follow up) are handled consistently, professionally and proactively and result in outcomes that demonstrate the Company’s commitment to regulatory compliance.
Ensures that a cross-functional team (e.g. Quality & Continuous Improvement (QCI) colleagues, GCTO Country Operations, other GCTO functional areas, Pharmacovigilance (PV), Global Regulatory Affairs and Clinical Safety (GRACS), IT, etc.) is fully informed and prepared to support any Regulatory Health Authority inspection, worldwide.
In partnership with the Global Inspection Coordinator and Head of CQO, maintain and QC the global inspection tracking system that tracks all GCP Regulatory Health Authority inspections, findings, responses and Corrective Action and Preventive Action (CAPAs), worldwide.
Act as the subject matter expert and primary point of contact for relevant functional areas on Inspection Management in order to provide real-time, proactive advice and guidance.
Escalate potentially significant inspection findings/compliance risks/impact to our Company Senior Management.
Develops the inspection management plan for each assigned and identified Regulatory Health Authority inspection, in conjunction with the applicable Cross-Functional Team.
CAPA Management Support:
Ensure that all actions and commitments related to audits and inspections are implemented in a timely manner. Track all inspection CAPA and regulatory commitments and checks evidence of completion.
Ensure repository of evidence in Documentum (containing evidence of CAPA and commitment completion, as well as other definitive inspection documentation) is complete for all Regulatory Health Authority inspections.
Provide guidance and support for CCQMs regarding inspections at a country level sites that require a company headquarters input.
Other activities:
Provide input into GCP Quality and Compliance Council regarding the QMS, RACT, Quality Plans and Regulatory Health Authority inspections status and results, including escalation of overdue CAPA commitments.
Assesses and provides input to strengthen company programs/strategies (e.g. QCV, HQ QCP) with an aim to increase Inspection Readiness.
Leads, drives, facilitates and/or supports remediation, prevention activities as process improvement and training, as needed.
Education:
Bachelor’s degree or equivalent in relevant health care area. Advanced or formal education in quality management or business management is preferred.
Experience:
Minimum of 6 years of relevant experience in clinical research including at least 2 years of direct experience with developing and managing clinical quality systems and management of regulatory inspections.
Knowledge and background in clinical development programs, clinical trial processes as well as quality management systems and quality control tools.
Expert knowledge of GCP/ICH and worldwide Regulatory Health Authority requirements.
Experience with delivering effective CAPA management solutions.
Experience with risk management tools and processes within the clinical quality framework.
Skills:
Superior oral and written communication skills in an international environment.
Ability to manage and develop others, including formal performance management when required.
Excellent project management and organizational skills.
Excellent teamwork and leadership skills, including conflict resolution expertise and discretion.
Lead cross-functional teams of business professionals within and outside our Research Division.
Act urgently for worldwide health authority inspection matters.
Analyze, interpret and solve complex problems.
Think strategically and objectively and with creativity and innovation.
Effectively interact with all levels of specialists & management and exert influence to achieve results.
Identify and summarize the key issues from audits and inspections and to develop and deliver lessons learned.
#EligibleforERP
MRLGCTO
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Residents of Colorado
Click here to request this role’s pay range.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
Pay Transparency Nondiscrimination
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.
Expected salary range:
$135,500.00 - $213,400.00Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
25%Flexible Work Arrangements:
RemoteShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
n/aOfficial account of Jobstore.
Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.
The Director, Quality Risk Management will report to the Quality and EHS Risk Monitoring and Review Lead, within the Quality Systems and Operations Compliance (QSOC) group.
Role is responsible to define the global strategy, development, implementation and maintenance of the PGS Quality Risk Management business process in accordance with industry expectations and regulatory requirements. The role will accomplish this by defining harmonized and standardized practices targeted at anticipating and avoiding unacceptable risks, aligning risk categories and methodologies for communication and fostering an informed culture whereby proactive behaviors and motivations are championed. In addition, the role will be responsible for the continuous improvement of the current Quality Risk Review process to ensure integration with both the Quality and EHS risk review and monitoring processes allowing for harmonized risk prioritization methodology and risk prioritization rules.
Role is responsible for leading cross-functional activities and teams that sustain, control, and improve the QRM processes within their remit. Additionally, the role will provide expertise in the collation, analysis, visualization, and presentation of risk information to enable customers to understand and apply QRM principles through knowledge transfer. This will involve the development of a business case for a longer-term digital strategy to manage all risk data.
Through your expertise and extensive knowledge, you will be able to foster a culture that promotes innovation and thrives on doing better for patients and healthcare.
Strong contributor to the design and development of the strategy for the global deployment of a Proactive Quality Risk Management program including governance, communication, infrastructure requirements, deployment timeline, tool application, monitoring.
Contributes innovative ideas for continuous improvement.
Collaborates and communicates at all levels to ensure local and global processes are well defined and opportunities for continual improvement are explored.
Maintains the group’s standards and supporting documents in support of current Regulatory requirements (ISO, ICH) and industry expectations for Quality Risk Management.
Leads and/or participates in risk reviews with the business leaders, Supports the aggregation, analysis, and interpretation of data from multiple internal and external sources; and reports patterns, insights, and trends into business performance, facilitate decision making and identify opportunities for improvement.
Risk expert who strategizes and creates new risk methodologies or customized risk tools for the quality management system as well as business/operational needs (e.g.: Contam Ctrl, risk profile, new facility design).
Develop and execute a training strategy that is flexible based on the needs of the organization.
May support the design and development of training materials (or facilitates service providers) in support of risk tools such as Failure Mode and Effect Analysis (FMEA), Preliminary Hazards Analysis (PHA), Hazard Analysis and Critical Control Points (HACCP) and other customized risk tools. Provides training on these tools either remotely, in person or through the creation of e-learning modules.
Leads the global Risk Community of Practice with the network focal points (Risk Champions) to share knowledge and best practices.
Facilitates critical, complex risk assessments, as needed.
Partner with digital on future electronic solutions to support and manage QRM activities and data.
Collaborates with the Business line Leadership as well as with partners outside of Quality for topics impacting our mission.
Lead or actively drive integration of risk principles on transversal projects, as assigned.
Support the development and generation of performance indicators to measure progress of implementation and effectiveness use of the QRM.
Bachelor’s degree in Engineering or science discipline or equivalent.
10+ years of quality assurance and/or business process experience in the medical device, biotech and/or pharmaceutical industry.
Quality Risk Management and/or medical device risk management experience.
Strong understanding and practical use of ICH, ISO, and cGMP regulations.
Recent experience demonstrating the capability to strategize, collaborate and execute on the successful completion of process improvements at a global level.
Strong collaboration and conflict management skills when working transversally across multiple Business Units to achieve global objectives.
High level of energy and enthusiasm and ability to energize others.
Proven critical thinking skills to be able to connect GxP requirements with business processes.
Effective verbal and written communication skills, including presentation skills. Able to communicate effectively at all levels of a matrix organization, as well as teach and present new ideas with clarity and simplicity.
Ability to influence Pfizer policies/positions in response to a changing regulatory landscape.
Master’s degree or equivalent.
Experience with the use of risk management tools (FMEA, HACCP, process mapping, and root cause analysis tools).
Knowledge of digital systems to manage data and reporting, experience using data to drive solutions to business challenges.
A willingness to contribute within a learning environment by sharing knowledge and best practices across the organization.
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
10-20% travel when required.
Work Location Assignment: Flexible.
Last day to apply: March 22, 2024.
Relocation assistance: No.
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.
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At HCSC, we consider our employees the cornerstone of our business and the foundation to our success. We enable employees to craft their career with curated development plans that set their learning path to a rewarding and fulfilling career.
Come join us and be part of a purpose driven company who is invested in your future!
Job Responsibilities
• Provide planning, implementation and monitoring of activities associated with regulatory and contractual requirements for government programs. Develop process and procedure flows to ensure that reports, or specific obligations mandated from government agencies are implemented by the appropriate business areas. Coordinate the development of policies and procedures designed to maintain the accuracy and timeliness of completing contractual requirements. Ensure that the process of filing certification and attestations with the government is documented.
• Analyze and oversee supportive data to prevent regulatory sanctions, foster regulatory relationships and integrate operations with regulatory requirements. This includes coordination with internal departments, i.e. Internal Audit, Special Investigations Department, Legal, as well as subcontractors to align for appropriate information collection and reporting. Work closely with Internal Audit and other business areas for the resolution of audit findings or other issues raised by the Government regarding non-compliance.
• Review and interpret regulatory documentation for adherence to standard criteria. Develop programs to accommodate corporate goals. Review filings made to government agencies.
• Perform reviews of various aspects of government programs and conduct investigations where necessary including investigations of any subcontractor, first tier entities, downstream entities and/or related entities.
• Prepare reports based on the completion of compliance reviews and investigations related to government programs.
• Design, implement, and monitor program projects and initiatives in all aspects of Government Programs.
• Serve as a resource on problematic issues generated from changing laws, regulations and guidance to maintain consistent/accurate interpretations.
• Participate in enterprise-wide initiatives and task forces in order to provide advice and guidance on compliance with government programs requirements.
• Manage reporting system to ensure that all contacts regarding possible non-compliance or misconduct involving a government program are properly logged, investigated and resolved including making recommendations to the Compliance Officer regarding whether disclosure should be made to the government, corrective actions, and disciplinary actions. Maintain documentation for each report of potential fraud, waste and abuse received through any reporting method (i.e. hotline, mail, in-person, exit questionnaires) which describes the initial report of non-compliance, the investigation, the results of the investigation, and all corrective actions and/or disciplinary action(s) taken as a result of the investigation.
• Direct research on laws and regulations to support investigative reviews related to government programs.
• Direct applicable audit functions to support investigative reviews of any potential wrongdoing related to government programs.
• Develop Corrective Action Plans and make recommendations regarding new policies and procedures based on risk assessments, compliance reviews, investigations or weaknesses.
• Identify needs and opportunities for communication to management regarding compliance issues and policies.
• Identify areas for training and communication to employees directly or indirectly related to Government Programs regarding compliance.
• Monitor Fraud, Waste and Abuse program as required under CMS guidelines and Medicaid contract including coordination with Special Investigations Department and Internal Audit
• Provide briefings on government programs requirements to the Compliance Officer, to the Board and its Committees and Compliance committees.
• Communicate and interact effectively and professionally with co-workers, management, customers, etc.
• Comply with HIPAA, Diversity Principles, Corporate Integrity, Compliance Program policies and other applicable corporate and departmental policies.
• Maintain complete confidentiality of company related business.
• Maintain effective communication with management regarding development within areas of assigned responsibilities and perform special projects as required or requested.
Required Job Qualifications:
* Bachelor’s Degree
* 8 years of auditing or investigative experience with a focus in government or compliance reviews.
* 5 years of managerial experience.
* Management and negotiation skills.
* Effective verbal and written communication skills.
Preferred Job Qualifications:
* 3-5 years of experience in a government programs health plan
*This is a hybrid role based in Albuquerque, NM and will sit in this office 3 days/week*
#LI-Hybrid
INJLF
#LI-EL1
Are you being referred to one of our roles? If so, ask your connection at HCSC about our Employee Referral process!
HCSC is committed to diversity in the workplace and to providing equal opportunity and affirmative action to employees and applicants. We are an Equal Opportunity Employment / Affirmative Action employer dedicated to workforce diversity and a drug-free and smoke-free workplace. Drug screening and background investigation are required, as allowed by law. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
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Driving Level One quality for assets within one or multiple Oncology Franchise / tumor types by maintaining ‘quality’ line-of-sight for assets/protocols within the Pfizer Oncology clinical portfolio.
With this focus, the Asset Quality Lead (AQL) role brings deep knowledge of Level One quality issues and risk areas within assets and across clinical trial programs. In partnership with the appropriate roles in Clinical Development & Operations, the AQL will work with Clinical Study Team Quality Leads within their assets to ensure asset and study level quality oversight, drive quality risk management activities across an asset, and will be instrumental in ensuring that asset and study level information is appropriately incorporated within the GCP QMS.
They will be the initial escalation point for stakeholders and asset teams for asset and study quality risk management, quality issues management and general GCP guidance.
ROLE RESPONSIBILITIES
Level 1 GCP Quality:
IQMP (Integrated Quality Management Plan) Development and Oversight at disease area and program level including integration within the Quality Management System (QMS), and ensuring individual asset and study level IQMPs are in place.
Escalation, Communication, and Governance – work within the Pfizer QMS framework, and in collaboration with PRD Quality, to ensure quality issues are escalated from study-level Asset Quality Leads and addressed appropriately. Represent their disease area / sub-portfolio within Pfizer Oncology Quality governance processes / meetings.
Inspection Readiness and Preparation, CAPA management – work within the Pfizer QMS framework, and in collaboration with PRD Quality to ensure inspection readiness and management of CAPAs.
Other Responsibilities:
Provide single point of accountability to clinical teams in their tumor type(s) for GCP advice and guidance.
Strategically utilize quality and compliance data to monitor portfolio quality and recognize potential risks and issues. Ensure project teams are aware of risks, issues and general quality state of asset/study. Analyze and interpret data from multiple sources to drive quality assessments.
Partner with Pfizer Oncology Clinical Development and Operations Analytics and Reporting and PRD Quality on the development and capture of quality metrics.
Provide Level 1 portfolio quality expertise on SQE investigation teams, as needed.
Design and execute Quality Compliance Assessments (QCA) within assets or CD&O process area and drive learnings across their tumor type(s).
Lead Level 1 quality review/assessment during Due Diligence and/or Integration activities.
Oversee program and study-level quality risk management activities (including IQMP activity) in their tumor type(s).
Drive consistent implementation of IQMP across program and study teams.
Facilitate IQMP development.
Assess QTL implementation by ensuring that quality metrics are monitored and that quality deviations are identified and addressed in a timely and appropriate manner.
Utilize QMS information, and integrate findings back into QMS, share learnings across assets and across Oncology Quality team.
Provide feedback to IQMP BPO to continuously improve IQMP approach.
Develop and present quality point of view at governance meetings.
Guide asset/study team on appropriate escalation pathways for quality concerns.
Advocate for study teams’ continuous improvement feedback on business processes to BPOs.
Communicate key quality information (e.g., inspection/audit learnings) across asset/study teams and serve as asset quality expert) in their tumor type(s).
Provide Study Team Inspection Readiness (IR) guidance and support; lead teams through pre-submission IR deep-dive in partnership with Audit and Inspection Quality.
Participate and guide teams with inspection preparation, conduct and response activities.
Support teams during inspections.
BASIC QUALIFICATIONS
A scientific or technical degree is preferred. In general, candidates for this job would have the following levels of experience:
Bachelors – 14 years or equivalent
MS/MBA – 12 years or equivalent
PhD/PharmD/MD – 9 years or equivalent
Extensive knowledge of ICH GCP and regulations in order to assess GCP situations and coordinate resolution activities across partner lines.
Expert knowledge, experience and expertise in clinical trial development, and operational quality management disciplines such as, quality and compliance assessments, quality assurance, CAPA management, deviation management, root cause analysis, audit and regulatory inspection process, and/or inspection readiness.
Ability to build strong network/knowledge/relationships with internal/external stakeholders.
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
PREFERRED QUALIFICATIONS
Skilled in project management.
Strong interpersonal skills, ability to influence, and ability to build and maintain excellent working relationships across lines in a matrix organization.
Experience of working on global initiatives or project teams. Appreciation of diverse needs of different regulatory requirements of different sites and countries.
Ability to lead cross-line global initiatives or root cause analysis for quality related process improvement.
Ability to implement strategies using coordinated and transparent metrics to track and manage compliance.
Spotfire and Excel skills/experience.
Other Job Details:
This is an individual contributor role
This role reports into the Sr. Director
*Last date to apply is March 16, 2024*
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.
Official account of Jobstore.
Senior Director, Compliance
Equifax is where you can power your possible. If you want to achieve your true potential, chart new paths, develop new skills, collaborate with bright minds, and make a meaningful impact, we want to hear from you.
The Sr. Director, Compliance, will provide subject matter expertise on managing regulatory inquiries and exams. The position will lead internal efforts to respond to requests from U.S. regulators with supervisory authority over Equifax, including the Consumer Financial Protection Bureau (CFPB) and State financial services and consumer protection agencies, manage regulatory engagements, and provide compliance guidance related to regulatory requirements. This position will manage individual project priorities, deadlines and deliverables, as well as support other compliance initiatives.
The Sr. Director, Compliance, will be a versatile team player, display leadership qualities, and be enthusiastic in addressing new challenges across the organization.
This role reports to the Deputy Chief Compliance Officer and will be a hybrid workplace model offering the flexibility to work remotely as well as in our office building in Midtown! (This is not a fully-remote role)
What You’ll Do:
Provide subject matter expertise on managing regulatory inquiries and exams.
Work closely with teams across Equifax to conduct investigations and prepare responses to regulatory inquiries.
Serve as the point of contact for teams across Equifax regarding regulatory inquiries and exams.
Manage document and information collection necessary to respond to information requests.
Interface with regulators and maintain positive and collaborative relationships.
Support the monitoring and testing of compliance controls for effectiveness.
Maintain visibility into emerging regulatory issues, including US laws and regulations that may impact Equifax.
Review company processes, policies, controls, operational requirements, and procedures to identify process improvements as they relate to compliance.
Manage metrics related to role and, where applicable, content for other leadership reports.
What Experience You Need:
Six (6) years minimum of relevant regulatory, compliance, or analogous experience, preferably in the financial services industry; or three (3) years of relevant law firm experience.
Bachelor's degree.
Excellent verbal and written communication skills with both technical and non-technical partners, with focus on informing, influencing, and relationship building.
Experience serving as the primary interface with regulators.
In-depth understanding of the financial services industry, including the regulatory landscape and consumer financial protection laws, specifically FCRA.
Experience interpreting financial services regulations.
Strong project management and coordination skills with proven ability to meet deadlines, prioritize assignments, and run multiple projects.
Demonstrated partnering skills, with experience coordinating initiatives with partners in a multinational organization.
What Could Set You Apart:
Direct experience with managing CFPB supervisory engagements
Juris Doctorate is strongly preferred.
Are you ready to power your possible? Apply today, and get started on a path toward an exciting new career at Equifax, where you can make a difference!
We offer comprehensive compensation and healthcare packages, 401k matching, paid time off, and organizational growth potential through our online learning platform with guided career tracks.
Equifax is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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Primary Location:
USA-Atlanta-One-Atlantic-CenterFunction:
Function - LegalSchedule:
Full timeOfficial account of Jobstore.
About Us:
Design Group operates from more than 45 offices in the United States and India, providing engineering, consulting and technical services for the world’s leading companies in the food and beverage, life sciences, advanced technology, industrial and other market sectors. Our nearly 1,500 technical and engineering experts have direct industry experience in industrial automation, control system integration, facility and process engineering, architecture, construction management, regulatory compliance, enterprise technology and other consulting services.
Job Description:
Director, Controls System Integration
Who You’ll Work With
You will join one of our 45 offices in the US, be part of a committed team of over 1500 professionals, and work in teams and directly with our clients doing work that is shaping the world around us. You will be welcomed into a rapidly growing business and team and empowered to make an impact. You will be valued, cared for, and challenged on your path to becoming a world-class professional consultant and surrounded by leaders who are committed to creating an environment that enables you to realize your own success and fulfillment.
When you join Design Group as a Director, Controls System Integration, you are joining a team that will challenge you and position you for growth. In this role, you will work with a team of industry experts to help the world’s leading companies solve their most difficult problems. You will join our Control System Integration Practice and partner with seasoned leaders, technical specialists, and subject matter experts to deliver the highest quality solutions to our clients with consistency and accuracy.
What You’ll Do
You'll work individually and in teams to support capital projects and implement solutions for our clients. Together, you will help our clients make critical changes to improve their performance and realize their most important goals.
What You’ll Bring
Our culture and commitment to our people is what sets us apart. We foster an environment of mutual respect, integrity, and unconditional interest in the individual and collective success of our professionals. Our model and entrepreneurial mindset offer a rewarding, challenging, and highly flexible path. As a Manager, Controls System Integration, you will build a meaningful and fulfilling career with the support of professional development resources and mentorships including our First Year Experience program, Individual Development Plans, and Career Path resources and tools. You will be surrounded by exceptional talent who will support your development as both a world-class engineer and a highly effective leader.
Feel like you're on the path to becoming a Director, Controls System Integration but you're not quite there yet? We'd love to connect with you to see if we can take you from where you are today and grow you into a Design Group Engineering Consultant.
At Barry-Wehmiller we recognize that people come with a wealth of experience and talent beyond just the technical requirements of a job. If your experience is close to what you see listed here, please still consider applying. We know that our differences often can bring about innovation, excellence and meaningful work—therefore, people from all backgrounds are encouraged to apply to our positions. Please let us know if you require reasonable accommodations during the interview process.
Barry-Wehmiller is an equal opportunity employer. M/F/D/V This organization uses E-Verify.
Company:
Design GroupOfficial account of Jobstore.
POSITION SUMMARY:
The Regional Head of Compliance will be responsible for leading and driving the Asia-Pacific Ethics and Compliance Program, managing the full spectrum of the compliance function from risk assessment, policymaking, SOP development, communications, training and third party compliance to enforcement, monitoring and investigations across the region.
By compliance, at Menarini we mean Anti-bribery and corruption (ABC) compliance and Trade Compliance based on the pharmaceutical industry laws and regulations, and standards set by the industry and Menarini group.
This leadership role will also be integral in providing guidance and support to the Country Compliance personnel and business teams on all aspects of the Menarini’s Ethics and Compliance Program.
KEY RESPONSIBILITIES:
KEY REQUIREMENTS:
Official account of Jobstore.
