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Job Description
Calling all passionate quality leaders! Join us as Associate Director & Qualified Person and make a significant impact on the success of our global clinical supply chain!
This pivotal role lets you build and lead a team, ensuring the flawless delivery of life-changing medicines worldwide.
Join us and make a real difference in patient lives.
Purpose of the position
In this crucial role, you'll directly support the Director, GDQ (Global Development Quality), by ensuring the smooth operation of our global clinical supply chain. You'll achieve this by overseeing all activities related to the disposition of clinical finished goods used in our worldwide trials. This includes building a dedicated team of two Senior QA Specialists at our Haarlem site.
Your primary focus will be ensuring the quality and compliance of investigational medicinal products (IMPs) throughout our Global Clinical Supply (GCS) Warehouse and Distribution network. You'll achieve this by overseeing all quality assurance activities related to Good Manufacturing Practice (GMP) compliance for the IMP license. Additionally, you'll design and manage a robust Quality Management System (QMS) for the clinical supply warehouse and distribution functions.
To maintain a seamless global clinical supply chain, you'll manage the distribution, and final disposition of clinical finished goods. This collaborative role will require you to work closely with internal and external partners to guarantee the on-time delivery of cGMP-compliant clinical supplies worldwide. You'll also be the company's voice during regulatory inspections pertaining to the IMP license and QMS.
Welcome to our team
The Global Development Quality (GDQ) organization is responsible for providing quality oversight of internal clinical packaging and distribution operations and supply chain management support for the end-to-end clinical supply chain.
Our team partners broadly across our company and our external partners to deliver continuous current good manufacturing practices (cGMP)-compliant clinical supply on time, every time, across the globe.
Primary responsibilities
Act as Quality site lead / QP for quality aspects of warehousing and distribution activities at the site in Haarlem.
Provide QP certification of batches of IMPs packaged for Clinical Trial use as required by directive 2001/20/EC.
Drive the implementation of the quality strategy at site.
Oversee the recruitment, management and development of the Quality team.
Lead the departmental and site preparation for internal and external audits
Champion the continuous improvement of the quality strategy by prioritizing, initiating and monitoring related improvements.
Legally responsible for the executions of releases and the execution of potential recalls.
Your profile
Master's degree in science or Pharmacy qualification (QP eligible).
6-8 years in pharma Quality Assurance, ideally with manufacturing & logistics experience.
Several years of experience as a Qualified Person (QP).
Strong team leadership & coaching skills.
Proven ability to analyze, recommend & lead quality initiatives.
Excellent communication with strong analytical thinking and EU GMP/cGMP knowledge.
Fluency in English (written & spoken)
Travel willingness (up to 10%)
What we offer
We welcome you to a truly global, dynamic and challenging environment with great opportunities for personal development. Our benefits are very competitive, and the summary below will give you an idea of what you can expect.
Competitive salary and a 3% year-end bonus;
35,5 days of leave;
Attractive collective health care insurance package with considerable reduction rates;
Solid Pension Plan;
Incentive Plan;
Travel allowance for commuting;
On-site sports facilities
Numerous training, coaching and e-learning modules for long term job opportunities and development
Current Employees apply HERE
Current Contingent Workers apply 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:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Not ApplicableShift:
Valid Driving License:
Hazardous Material(s):
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Job Title
Assistant Chief EngineerJob Description Summary
Responsible to ensure the proper efficient operations and maintenance of the mechanical electrical and plumbing systems for the assigned facility. The performance of all necessary maintenance and operational tasks are developed to assure maximum life and reliability of all mechanical/ electrical/plumbing systems. Typically, this position does not have a Chief Engineer on-site at the building and is sometimes the solo engineer at the building. This position may also include the supervision of maintenance staff at the building depending on the size and complexity of the assignment.Job Description
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES
• Assist with or conduct the daily operations and maintenance of the mechanical, electrical and plumbing systems and general maintenance requirements for the buildings
• Supervise maintenance staff when applicable and assign, and monitor maintenance activities and projects
• Perform preventive maintenance duties, including changing filters, lubricating motors, replacing lamps, ballasts and fixtures, Inspecting and adjusting belts, replacing motor bearings, aligning shafts, and other inspections and maintenance recommended by equipment manufacturers
• Recommend improvements to the preventive maintenance program on an ongoing basis
• Develop and maintain effective building-specific maintenance procedures
• Coordinate maintenance efforts with outside contractors and technicians
• Maintain stock and inventory control
• Respond immediately to emergency situations (fire, evacuation, equipment failure, etc.) and customer concerns
• Comply with all applicable codes, regulations, governmental agency, and company directives as related to building operations and practice safe work habits
• Ensure management team is informed of current building operations by compiling and submitting monthly reports
• Complete all required C&W Safety Training as scheduled annually.
• Comply with C&W Uniform Dress Code while working and maintain a neat and clean appearance while on the property at times other than working hours
KEY COMPETENCIES
• Communication Proficiency (oral and written)
• Organization Skills
• Technical Proficiency
• Decision Making
• Problem Solving/Analysis
IMPORTANT EDUCATION
• High School Diploma or GED Equivalent
• Graduate of apprentice program or trade school preferred
IMPORTANT EXPERIENCE
§ 5+ years of related trade experience in operating mechanical, electrical and plumbing systems in a commercial property setting
ADDITIONAL ELIGIBILITY QUALIFICATIONS
• Appropriate license/permit for trade as may be required, i.e. Journeyman or Master Electrician License, City Licenses, Operators License, Steam Engineers License, etc.
• Possess a valid “Universal” level certification for CFC and HFC based refrigerants (EPA Section 608); to service, repair, or dispose of equipment that could release ozone depleting refrigerants to the atmosphere or any similar combination of education and experience
• Possess and maintain a valid driver’s license and good driving record with periodic checks
• Basic Computing Skills in Outlook, Excel & Word
• Experience in operation, maintenance and basic repair of HVAC, boilers, heaters, pumps, refrigerant systems, compressors, water systems, etc.
• Knowledgeable in energy management systems, techniques and operations.
• Thorough knowledge in all building systems operations, maintenance and repair
May be only maintenance staff member on duty during certain shifts; may be required to work extended periods of time without relief when responding to priority/emergency situations (including overtime type assignments); may require shift work and/or on call duties
WORK ENVIRONMENT
This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Regularly required to travel outside between properties in varying weather conditions.
PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
• Must have ability to stoop, stand, climb, frequently lift a minimum of 50 lbs. of equipment (pumps, tools, ladders) and safely install rigging/lifting devices
• Regularly required to crouch and reach to install/move equipment by bending forward at the waist or by bending legs and spine
• Involves movement between departments, floors, and properties to facilitate work
• Ability to speak clearly so others can understand you
• Ability to read and understand information presented orally and in writing
• Regularly required to utilize vision abilities, allowing reading of printed material, drawings, and schematics
AAP/EEO STATEMENT
C&W provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law. Further, the company takes affirmative action to ensure that applicants are employed and employees during employment are treated without regard to any of these characteristics. Discrimination of any type will not be tolerated.
OTHER DUTIES
This job description is not designed to cover or contain a comprehensive list of activities, duties or responsibilities that are required of the employee. Other duties, responsibilities and activities may change or be assigned at any time with or without notice.
In compliance with the Americans with Disabilities Act Amendments Act (ADAAA), if you have a disability and would like to request an accommodation in order to apply for a position at Cushman & Wakefield, please call the ADA line at 1-888-365-5406 or email HRServices@cushwake.com. Please refer to the job title and job location when you contact us.
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Job Responsibilities:
As a Systems Engineer with Active Directory experience, you will play a crucial role in our IT team.
Requirements:
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Do the work that matters
We’re looking for Chief Engineer – Workflow Technology, who’ll be responsible for providing technology thought leadership to senior leaders for a distinct business area (in CBA we call this a Crew) undergoing an Agile transformation.
Essentially, you’ll partner with the senior leaders, driving the technology direction for that business area, translate business strategy into technical strategy and be responsible for defining its technical roadmaps. You’ll also help business leaders understand technology concepts by working at the forefront of all technology decisions.
We support our people with the flexibility to balance where work is done with at least half your time each month connecting in office. We also have many other flexible working options available including changing start and finish times, part-time arrangements and job share to name a few. Talk to us about how these arrangements might work for you.
We are seeking people who can:
Work at the Executive level, have confidence to present to the senior stakeholders (GM/EGM/C-level) and provide them technical insights in a business context;
Define execution plans to achieve business outcome, this includes technical solution and roadmap, resource allocation and prioritisation, cost implication and optimisation opportunities;
Assist in defining technical annual operating plan and define quarterly OKRs to achieve company and business unit goals. Collaborate effectively with stakeholders to manage priority and dependencies.
Embed IT performance metrics to help members understand how they drive overall crew performance.
Ensure IT risks, technical debt and the associated impacts are understood including helping the business area prioritise management of issues/incidents.
We’re interested in hearing from people who:
Are inspirational senior technology leaders, adept in leaning into technical challenges, helping create clarity, providing hands-on assistance and effectively prioritising work. Create supportive and trusted working environments, promoting collaboration and creative thinking across teams.
Are highly experienced in software / systems engineering, working in an Agile environment.
Are able to assess and monitor modern technology tools, platforms and applications to deliver solutions and leading-edge products of high quality, while operating at peak performance
Can show the ability to work across teams and influence great outcomes, solve problems and operate at times with ambiguity.
Are comfortable influencing and challenging business and technology stakeholders.
Have experience in managing diverse stakeholders and expectations and juggle multiple priorities without sacrificing team alignment, engagement, productivity and velocity.
Show excellent commercial acumen with experience in strategic planning.
Tech skills
We use a broad range of tools, languages, and frameworks. We don’t expect you to know them all but experience or exposure with some of these (or equivalents) will set you up for success in this team;
Workflow application experience-Pega, Appian, Salesforce, Service Now etc
CI/CD pipeline tools (e.g., GitHub Actions, Jenkins, AWS (Amazon Web Service) CloudFormation + AWS Code Pipeline, Azure DevOps, Bitrise)
Experience in automated deployment of application in different hosting technologies (AWS cloud native, Kubernetes, VMware, VMs)
Administrative level understanding of Source code control tools (e.g., GitHub, AzureDevOps)
If this sounds like the role for you then we would love to hear from you. Apply today!
If you're already part of the Commonwealth Bank Group (including Bankwest, x15ventures), you'll need to apply through Sidekick to submit a valid application. We’re keen to support you with the next step in your career.
We're aware of some accessibility issues on this site, particularly for screen reader users. We want to make finding your dream job as easy as possible, so if you require additional support please contact HR Direct on 1800 989 696.
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Title:
Chief Engineer (Top Secret)KBR is searching for a highly skilled Chief Engineer to support development of first-of-kind operational space or space related missions for the Space Rapid Capabilities Office (RCO). As the Chief Engineer, you will lead a small team of technical specialists and engineers through requirements development, design reviews, and provide technical oversight of fielding, testing, operations, and sustainment of large-scale optical systems. A successful candidate should be a leader and problem solver with a proven ability to deliver superior results as part of a high performing team in a high-profile, fast-paced environment. The candidate will apply advanced principles, theories, and concepts for highly classified systems, while also effectively communicating complex results with management and executive leadership.
In this position, you will provide System Engineering Technical Assistance (SETA) to the Space RCO at Kirtland AFB, NM. The Space RCO is one of three US Space Force acquisition organization and is the one specializing in delivering first-of systems to fill quick-turn needs to deliver operational capability to the USSF. For each project, Space RCO sets up small, agile and empowered teams, to include program manager, technical specialists, contracting, finance, security, and they use right acquisition strategies to set the effort up for success. You will work in one of these small, highly empowered teams where every team member is directly responsible for the success of the program.
Role and Responsibilities*
Required skills:
Desired skills:
Education:
Clearance:
Work Location & Travel:
KBR is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, disability, sex, sexual orientation, gender identity or expression, age, national origin, veteran status, genetic information, union status and/or beliefs, or any other characteristic protected by federal, state, or local law.
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This posting will accept applications until 11:59 PM on March 22, 2024. Please submit your application prior to this closing date to ensure consideration.
The Department of Transportation and Infrastructure (DOTI), through its employees, enhances the quality of life in Denver by efficiently delivering effective, high quality, safe and equitable public infrastructure and services, including transportation planning, design and construction; major projects, maintenance of streets, bridges and storm and sanitary sewers; residential trash, recycling and compost collection; and oversight and regulation of use of the public right-of-way including on-street parking. We employ a culture of safety throughout the department to strengthen workplace health and organizational performance. For more information, please visit www.denvergov.org/DOTI
DOTI’s Commitment to Equity:
The City and County of Denver offers a competitive salary commensurate with education and experience. The full salary range for this position is $174,899 - $297,328/year. However, our target hiring range is between $190,000 - $240,000/year commensurate with education and experience.
We also offer generous benefits for full-time employees which include but is not limited to:
The City and County of Denver supports a hybrid workplace model. Employees work where needed, at a job site several days a week and off-site as needed. Employees must work within the state of Colorado on their off-site days. In this position you can expect to work on site at the Wellington Webb Building or at our Wastewater Building at least three days a week.
DOTI has an opening for the Chief (City) Engineer. This executive level management position will be responsible for providing visionary leadership for the City transportation and city infrastructure business lines, the delivery of effective and efficient customer-focused services, and the execution of business strategies with a focus on continuous improvement and data-driven results. The City Engineer will direct multiple engineering and planning related divisions for the Department of Transportation and Infrastructure (DOTI) including establishing a multi-year vision and strategic plan for the business lines, optimizing resource allocation, and ensuring the organization accomplishes annual goals and strategic initiatives.
Additional responsibilities for this role include, but are not limited to:
You are a visionary who possesses demonstrated leadership experience as an Engineer on large, complex, multidisciplinary design and construction projects. You are a well-rounded Engineering professional with the highest professional ethics, robust leadership skills, and a passion for solving complex programmatic issues.
Additionally, you will possess:
Job Profile
CE2786 City EngineerTo view the full job profile including position specifications, physical demands, and probationary period, click here.
Position Type
UnlimitedPosition Salary Range
$174,899.00 - $297,328.00Starting Pay
$190,000 - $240,000/year commensurate with experience and educationAgency
Dept of Transportation & InfrastructureThe City and County of Denver provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identity, national origin, disability, genetic information, age, or any other status protected under federal, state, and/or local law.
Applicants for employment with the City and County of Denver must have valid work authorization that does not require sponsorship of a visa for employment authorization in the U.S.
For information about right to work, click here for English or here for Spanish.
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The Space Systems Research Branch within the Leidos Innovation Center at Leidos currently has an opening for a Senior Principal Chief Payload Engineer to work in our San Diego, CA office. This is an exciting opportunity to use your experience leading the engineering design, build and test Overhead Persistent Infrared (OPIR) payloads where Leidos is transforming the payload solutions for the future.
Primary Responsibilities
Basic Qualifications
Preferred Qualifications
While subject to change based on business needs, Leidos reasonably anticipates that this job requisition will remain open for at least 3 days with an anticipated close date of no earlier than 3 days after the original posting date as listed above.
The Leidos pay range for this job level is a general guideline only and not a guarantee of compensation or salary. Additional factors considered in extending an offer include (but are not limited to) responsibilities of the job, education, experience, knowledge, skills, and abilities, as well as internal equity, alignment with market data, applicable bargaining agreement (if any), or other law.
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Job Description
POSITION SUMMARY:
The Associate Director, Information Systems Management entails providing risk based oversight to Computerized Systems Life Cycle activities across broad spectrum of technologies ranging from Automated Systems to Enterprise Wide systems and Software-as-a-Service (SaaS) solutions. This role ensures risk-based, overall integrity of electronic data across all stages of data life cycle and leads development and refinement of quality management systems standards and policies to align with various GxP regulations.
RESPONSIBILITIES:
The responsibilities of this position will include, but are not limited to, the following:
Key Technical Knowledge, Skills and Competencies:
Education and Experience:
Hybrid-Eligible Roles
In this Hybrid-Eligible role, you can choose to be designated as:
Hybrid: work remotely up to two days per week; or select On-Site: work five days per week on-site with ad hoc flexibility.
#LI-Hybrid #LI-AR1
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.
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Job Description
GENERAL POSITION SUMMARY
The Associate Director of Quality Sterility Assurance and Aseptic Controls is recognized as having expertise in the principals and application of sterile processing technologies and providing technical support for manufacturing of cell and gene therapy programs within cGMP manufacturing. This role will partner with stakeholders to define strategies for microbial control activities in key areas that include facility and equipment design and qualification (e.g. cleanroom, isolators, autoclaves, etc.), environmental qualification and monitoring programs, and operational practices (e.g. gowning, cleaning and sanitization, etc.). This individual will interface with internal and external manufacturing sites to support the maintenance of critical cGMP aseptic activities and provide technical support for the overall contamination strategy and facility monitoring programs.
The incumbent will work cross-functionally with colleagues from Manufacturing, Manufacturing Science and Technology, Global Engineering, Validation, Process Engineering, EM/UM Quality Control, CMC Regulatory, and Quality Operations on the design of processes and technologies required to produce aseptic drug product to successfully commercialize an exciting and diverse portfolio of innovative cell and gene therapy pipeline programs. In addition, the successful candidate will be experienced in the fields of aseptic process technologies, microbial testing, environment and critical utilities monitoring programs, and in the design, commissioning, and qualification of facilities, utilities, and equipment systems.
This role will report to the Director of Quality Validation and Engineering within the Vertex Cell and Genetics Therapies QA group.
KEY DUTIES AND RESPONSIBILITIES
Sterility Assurance and Aseptic Controls
Operations – Facilities, Validation, and Engineering Support
Audit / Inspection Support
Deployment of QMS and Establishment of Compliance Expectations
REQUIRED EDUCATION AND EXPERIENCE
#LI-AR1
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.
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Relocation Assistance Eligible:
YesReferral Payout Eligible:
YesContinue growing with our family.
Our team members make it happen. If you want to continue to grow in a new role internally and see a position that looks right for you, we encourage you to apply!
Thanks for your commitment to Tyson Foods.
Management Level:
M3SUMMARY:
The Associate Director Food Safety and Quality Assurance (FSQA) position is responsible for ensuring products and processes meet the highest standards of compliance for food safety and quality within Tyson Facilities.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
REQUIREMENTS:
Work Shift:
1ST SHIFT (United States of America)Tyson is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will be considered without regard to race, national origin, color, religion, age, genetics, sex, sexual orientation, gender identity, disability or veteran status.
We provide our team members and their families with paid time off; 401(k) plans; affordable health, life, dental, vision and prescription drug benefits; and more.
CCPA Notice. If you are a California resident, and would like to learn more about what categories of personal information we collect when you apply for this job, and how we may use that information, please read our CCPA Job Applicant Notice at Collection, click here.
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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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(The role is only open to candidates based in Poland)
Job Overview
This role is assigned to designated Delivery Unit(s), country/countries, sponsor(s), business units(s), and/or specific tasks as defined by the line manager (LM). Contributes to the development and is responsible for the implementation of specific quality improvement initiatives as agreed with the relevant Head(s) of assigned business lines. Provides advice and supports relevant key stakeholders with regards to quality control, risk assessment, risk management, and corrective/preventive actions.
Essential Functions
• Contributes to the development, and supports implementation of the Quality Management Plan within the scope of the assignment this will include: Planning and executing the Quality Management activities. Risk identification and assessment through data review and quality control processes. Providing support in risk mitigation, in planning corrective/preventive actions, and guidance for improvement. Supporting the assigned business line management and staff to enhance effectiveness in project delivery.;
• Cooperate closely with the relevant business lines and other stakeholders, support maintaining focus on quality in project delivery.
• Provides advice and support to teams within the assigned business line on all aspects of Good Clinical Practice (GCP) compliance.
• Works in close cooperation with teams to manage non-compliance, quality issues
• Assist in planning corrective/preventive actions, as applicable according to Standard Operating Procedures (SOPs).
• Informs the assigned business line and Quality Assurance of quality issues according to SOPs.
• Works closely with Quality Assurance and assigned business staff in case of suspected misconduct, as required by the applicable SOPs.
• May provide assistance during audits and regulatory inspections to the teams to the extent agreed with the line manager, as required by the applicable SOPs.
• Acts as the primary contact for Quality Assurance on quality matters – on the level of the assignment, attend meetings/teleconferences.
• Prepares periodic reports to business lines on quality related matters, risk assessments and specific quality improvement initiatives.
• Manages staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work, appraising performance and guiding professional development, rewarding and disciplining employees, addressing employee relations issues and resolving problems. Approve actions on human resources matters.;
• Upon agreement with the Head of relevant business line: Performs any other reasonable tasks as required by the role.
Qualifications
• Bachelor's Degree Req
• Typically requires 5-7 years of prior relevant experience.
• Requires deep knowledge of one or more related job areas typically obtained through advanced education combined with experience.
• Sound working knowledge of relevant terminology, International Conference on Harmonization (ICH), Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), applicable regulatory requirements, quality management processes.
• Excellent organizational, interpersonal and communication skills.
• Excellent judgement and decision-making skills.
• Demonstrated leadership and line management skills.
• Excellent influencing and negotiation skills.
• Strong computer skills including Microsoft Office applications.
• Excellent problem-solving skills.
• Demonstrated ability to work in a matrix environment.
• Ability to lead and motivate a clinical team also required.
• Ability to travel within the region/country.
• Ability to establish and maintain effective working relationships with co-workers, managers and clients.
• Fluent in English.
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com
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Job Summary
The Director, Quality Management provides strategic oversight, leadership and direction to the Quality function and will be accountable for the CHPS (Cardinal Health Packaging Solutions – repackaging & bulk up) business unit within the Cardinal Health Pharmaceutical Segment.
What Quality Management contributes to Cardinal Health
Quality Management is responsible for developing and implementing quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications to ensure that products and services are reliable, safe and effective.
Demonstrates knowledge of quality systems and approaches.
Demonstrates an understanding of the relevant regulations, standards and operating procedures.
Demonstrates ability to perform investigations / root cause analysis and develop corrective actions.
Demonstrates an understanding of the requirements and has the ability to perform gap assessments to those requirements.
Demonstrates an understanding of quality concepts such as: cost of quality, analytical metrics and / or statistics, trending, quality planning, validation, CAPA and problem solving.
Works cross-functionally and has the ability to interpret the requirements as well as educate and influence others on those requirements.
Build and foster One Team Quality Culture.
Responsibilities
Responsible for the release of final product before distribution to the market, including submission (by ensuring preparation of the adequate documentation) of the product.
As the head of the Quality Team for CHPS, ensure release of the final product in compliance with Good Manufacturing Practices, with the marketing authorization and regulatory requirements.
Manages deviations related to final product packaging components and/or raw materials disposition (e.g. root cause analysis, CAPA plan identification and follow-up) in a timely manner.
Ensures CAPAs for which the team is responsible are followed and closed within defined timelines.
Must be able to approve emergency change controls but understanding the nature of the content including intermediate steps and make the link with the final product and any regulatory requirement.
Understands release product issue and evaluate their potential impact on product quality and compliance.
Escalates complex issues to leadership in a timely manner.
Manages professional employees, frontline supervisors and business support staff while maintaining strong relationships with customers.
Prioritizes and ensures work is delivered in an efficient way.
Provides daily problem solving.
Represents Quality in meetings related to his/her area of responsibility internally and externally.
Performs other duties as assigned.
Qualifications
Bachelors and Advanced degree in related field or equivalent work experience, preferred.
10+ years’ experience in Biopharma, Pharmaceutical or Medical Device regulated fields.
At least 7-10 years of relevant work experience with 21 CFR 210, 211 in the FDA regulated industry (Pharmaceutical or Medical Device), ISO and/or DEA regulated environments.
Experience with equipment qualification, software validation, test method validation, and/or process validation.
Works well with others and understand how to be successful in a team environment, especially since customer facing.
Detail oriented, organized, able to multi-task, a self-starter and self-motivated.
Proficient in Microsoft Word and Microsoft Excel and possesses strong technical writing skills.
What is expected of you and others at this level
Provides leadership to managers, experienced quality professionals and manage front line supervisors
Manages an organizational budget
Develops and implements policies and procedures to achieve organizational goals
Assists in the development of functional strategy
Decisions have an extended impact on work processes, outcomes, and customers
Interacts with internal and/or external leaders, including senior management
Persuades others into agreement in sensitive situations while maintaining positive relationships
Anticipated salary range: $112,500 - $181,650
Bonus eligible: Yes
Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being.
Medical, dental and vision coverage
Paid time off plan
Health savings account (HSA)
401k savings plan
Access to wages before pay day with myFlexPay
Flexible spending accounts (FSAs)
Short- and long-term disability coverage
Work-Life resources
Paid parental leave
Healthy lifestyle programs
Application window anticipated to close: 6/8/2024 *if interested in opportunity, please submit application as soon as possible.
Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.
Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.
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CLA is a top 10 national professional services firm where our purpose is to create opportunities every day, for our clients, our people, and our communities through industry-focused wealth advisory, digital, audit, tax, consulting, and outsourcing services. Even with more than 8,500 people, 130 U.S. locations, and a global reach, we promise to know you and help you.
CLA is dedicated to building a culture that invites different beliefs and perspectives to the table, so we can truly know and help our clients, communities, and each other.
Our Perks:
Flexible PTO (designed to offer flexible time away for you!)
Up to 12 weeks paid parental leave
Paid Volunteer Time Off
Mental health coverage
Quarterly Wellness stipend
Fertility benefits
Complete list of benefits here
CliftonLarsonAllen, LLP is hiring an Assurance Director or Manager to support our Nonprofit practice, in Massachusetts. Office locations include: Boston, Quincy, Lexington, Andover, and Worcester.
How you’ll create opportunities in this Assurance Manager or Director role:
Manage and develop relationships with great clients.
Assist clients in obtaining necessary funding to continue to positively impact their community.
Assist clients with meeting their audit and financial planning objectives by using a range of tools.
Be creative with staff development, mentoring, and overseeing client engagement teams.
Lead the engagement progress by monitoring time budgets and deadlines for adherence.
Communicate important developments to the engagement principal along with facts, conclusions, and recommendations.
What you will need:
You have a Bachelor's Degree in Accounting, Finance, or a related field.
You have a minimum of 6 years of public accounting experience with emphasis in financial statement preparation and audits.
CPA license certification is required.
You jump at the chance to help others and you’re ready to lead a team of high-performing people.
You have a knack for solving issues and can confidently bring solutions to the table.
You love to work with clients’ to help their businesses succeed strategically.
#LI-BV1
Equal Opportunity Employer /AA Employer/Minorities/Women/Protected Veterans/Individuals with Disabilities.
Click here to learn about your hiring rights.
Wellness at CLA
To support our CLA family members, we focus on their physical, financial, social, and emotional well-being and offer comprehensive benefit options that include health, dental, vision, 401k and much more.
To view a complete list of benefits click here.
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