Job Description

General Summary:

The Senior Director, Quality GLP, Biomarkers and Research has overall accountability for strategic leadership and oversight of the end-to-end quality assurance strategy for proactive, risk-informed, and sustainable quality oversight and compliance with regulatory expectations across Vertex processes for clinical evidence generation and product vigilance

Key Duties and Responsibilities:
• Serves as a strategic partner to functional leaders across product modalities responsible for Research (including both non-regulated and GLP work), Biomarker Development, and Diagnostics in assuring appropriate quality/compliance oversight of processes and systems supporting effective delivery of these programs and the rigor and integrity of associated data.
• Defines strategy for and oversees tactical execution strategic plan by direct reports to provide effective oversight of research, assay development in support of pre-clinical and clinical research, GLP animal studies, in vitro diagnostic development, and all R&D vendors. Assures operational quality activities are informed by risk and assure the integrity of data submitted to regulatory authorities and in external forums.
• Responsible for assuring that key research & pre-clinical studies (internal and external) are performed in accordance with good scientific practices, good laboratory practices, Vertex policies and procedures and relevant local, regional, and international requirements.
• Leads an operational quality team responsible for identifying and anticipating potential compliance issues that may impact the ability to meet business goals, developing and implementing methods of improvement and resolution in a pragmatic and effective manner
• Oversees effective, timely, and appropriate identification, remediation, and escalation of quality issues in key Research, GLP, Biomarker, IVD and vendor governance-related activities across Vertex.
• Provides periodic updates on the overall health of Research, GLP, Biomarker, and IVD development-related processes and systems to functional leaders across Research, Biomarker Development, and Diagnostics.
• Oversees and assures timely and effective communication of summary trending and other insights on the quality of delivery in research, preclinical, biomarker, IVD work, and vendor performance to relevant business and quality leaders and in relevant forums.
• Oversees Inspection Readiness activities in collaboration with business and Quality Assurance partners related to research, GLP, biomarkers, IVD development activities.
• Chairs relevant operational governance meetings (e.g. QLT)
• Serves as the R&D Quality lead and oversees and guides staff participating in strategic cross-functional initiatives (e.g. Research Ethics, TRPM to improve quality, data integrity, and compliance to regulatory requirements and standards, ensuring a aligned Quality point-of-view is represented.
• Maintains an in-depth understanding of business principles, industry dynamics, regulatory environment, market trends, and specific operational details related to Research, GLP, Biomarker, and IVD activities.
• Drives and oversees implementation of new and evolving regulatory requirements related to areas of responsibility.
• Leads and/or participates in industry forums and external initiatives related to areas of responsibility to influence policy development related to oversight of these activities, as aligned with functional leadership and Vertex interests.
• Provides strategic direction, oversight, coaching and mentoring to direct reports.

Education and Experience:

• M.S. (or equivalent degree) and 10 +years of relevant work experience, or
• B.S. in a scientific or allied health field (or equivalent degree) and 15+ years of relevant work experience, or relevant comparable background

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

Position Summary:

This is a 12-month contractual position. This position is responsible for supporting the Regional Operations and Lam Quality Program in the region and primarily working on generating and analyzing first level data, report compilation and administrative support.

Job Responsibilities:

Support Quality Management Program

1. Build customer trust through consistent communication and reporting.
2. Contribute to the Quality Community & collaborate with all regional QPLs.
3. Admin and support role in the Lam Quality Management through the IQMS (Integrated Quality Management System):

- IRF (Investigation Request Form) submission review & approval

- GQ (Global Quality) report Update requested information (E.g. damage code)

- GQ report NCe (Non-Conformity external) with Inv Group - Field Service

- Reverse logistic report

- GQ report Needing Action (FQM (Functional Quality Manager)/ QPL (Quality Program Lead)) Report

• ETS (Event Tracking System) tickets follow up
• NCe audits

Regional Operations Support

• Compilation of CADO (Cost Allocation Distribution Options), mandatory retrofit and tool in install reports and follow up with end users for closure.

Job Requirements:

• Professional certificates or tertiary education equivalent (A levels, Diploma, Nitec)
• Possesses strong inter-personal, negotiation and communications skills.
• Possesses strong Microsoft Office application skills
• Strong analytical skills and experience in MS PowerBI/ Qlik Sense application will be advantageous

JOB DESCRIPTION:

• Responsible for day-to-day business data management and regular business report preparations, which includes SAP material master maintenance, data integrity checking and statistics.
• Daily monitoring of basic system health and to flag out any inconsistency in API/System functions when found/reported.
• Daily monitoring of system backend jobs and ensure transactional data are interfacing in healthy state with external/internal system.
• To support Business Analytics, extracting and reorganizing original data, dealing with data related issues with other departments.
• Responsible for data preparation, data mining, to create/identify opportunities through analytics, to optimize business objectives.
• Communicate findings and insights to relevant stakeholders in order to assist Manager in making data-driven decisions in KPI assessments.
• Drive continuous improvements /optimization of campaign performance tracking report with business while complying to A*STAR policies.

REQUIREMENTS:

• Bachelor's Degree or Diploma (with at least 5 years or more relevant experience), preferably Business Analytics, Information systems or Computer Science.
• Strong analytical skills, with experience solving problems using data and providing practical business insights.
• Self-Starter with a strong sense of urgency.
• Aptitude to challenge the status quo, think outside the box, and question what has been done.
• Comfortable with dealing with sets of data points from different sources.
• Qualities of matured thinking, dependable and requires minimum supervision.
• Excellent communication skills (oral and written).

The above eligibility criteria are not exhaustive. A*STAR may include additional selection criteria based on its prevailing recruitment policies. These policies may be amended from time to time without notice. We regret that only shortlisted candidates will be notified.

Description:
● Help establish and maintain effective regulatory and AML compliance
framework and internal controls within the firm
● Support the compliance team in reviewing Know-Your-Customer (KYC) such as
the adequacy of Source of Wealth narrative and corroboration, transaction
monitoring (KYT) operations, conducting thorough due diligence for new and
existing clients within the crypto industry.
● Conduct investigations on the transaction monitoring alerts and assist with
the suspicious transactions reporting filing.
● Work with internal stakeholders to ensure compliance with all applicable
regulatory and licensing requirements and conditions.
● Keep abreast of the latest regulatory developments in Singapore pertaining to
payments services and digital assets.
Requirements:
● Bachelor's degree in accounting, finance, economics, law or equivalent work
experience
● At least 3 years of relevant working experience in compliance or related field

● Strong knowledge of AML/CFT requirements in Singapore and the Payment
Services Act in particular
● Previous experience with KYC and KYT in a crypto or financial setting is highly
beneficial.
● Team player with strong communication and interpersonal skills

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers.

We foster an inclusive culture and are looking for diverse, talented people to join Alcon. As a Quality Engineer I in the Complaints Department you will be trusted to work on supporting product improvement at Sinking Spring, PA.

In this role, a typical day will include:

• Provide complaint trending analyses to support improvement of products manufactured in the facility and prepare trend reports for site Complaint Review Board.
• Maintain knowledge of product quality controls and failure modes.
• Evaluate complaint samples and provide training for complaint sample evaluations.
• Initiate and perform investigations, (Complaint investigations and Non-Conformance investigations) and Corrective Actions / Preventive Actions (CAPA) while providing guidance and approval, maintain & follow up on Quality Corrective Action Plans using Root Cause analysis tools and data evaluation.
• Provide Progress Reports and trending to show product quality levels and respond to regulatory requests.

Additional responsibilities:

• Support continuous improvement projects, quality issue resolution, Non-conformances/CAPAs, and Quality System activities for the complaint handling process.
• Use various statistical and non-statistical problem-solving tools as part of analysis of data, issues, or improvement opportunities.
• Actively participate and chip into routine platform-based meetings and change control activities.
• Provide Quality Assurance support and guidance on medical device products, process, and document changes to assure compliance with site Quality Systems procedures.
• Consistent track record to handle time efficiently and meet target quotas under pressure.

WHAT YOU'LL BRING TO ALCON:

• Bachelor’s Degree or Equivalent years of directly related experience (or high school +8 yrs.; Assoc.+4 yrs.)
• The ability to fluently read, write, understand and communicate in English
• Work hours: M-F
• Travel Requirements: Minimal
• Relocation assistance: No
• Sponsorship available: No

HOW YOU CAN THRIVE AT ALCON:

• See your career like never before with focused growth and development opportunities
• Join Alcon’s mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career!
• Alcon provides robust benefits package including health, life, retirement, flexible time off for exempt associates, PTO for hourly associates, and much more!

ATTENTION: Current Alcon Employee/Contingent Worker

If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.

Find Jobs for Employees

Find Jobs for Contingent Worker

  

Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to alcon.recruitment@alcon.com and let us know the nature of your request and your contact information.

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for diverse, talented people to join Alcon.

The Quality Site Head - Huntington develops, maintains, and improves quality systems and assures products meet established specifications and are in compliance with various quality and regulatory standards. They are responsible for Quality Operations for our Surgical Devices Manufacturing facilities.

Major Accountabilities: 

• Responsible for all quality and compliance related activities and decisions for the applicable Surgical Manufacturing Facility, and for implementing the Site quality management programs. 
• Lead the site’s overall quality function including; Quality Assurance, Quality Control, Quality Systems, and Compliance.
• Appointed Site Management Representative, per the appointment letter. Participates in the design, implementation, monitoring and maintenance of an effective Quality Management System. 
• Demonstrate strong and visible support for the Quality Management System, ensure its implementation throughout their organization and advocate continuous improvement. 
• Ensure products comply with market authorization and GMP requirements and advocate continuous improvement during manufacturing, distribution and shelf life, both for products manufactured at the site and for Third Party products managed by the Site or Functional Unit 
• Ensure management training on and awareness of quality and compliance requirements and systems. 
• Ensure appropriate disciplinary actions are taken in case of willful or negligent GxP and Quality Management System violations up to and including termination of employment. 
• Assess the conclusions of periodic review of process performance, product quality and of the Quality Management System. 
• Monitor effectiveness of Quality Management Systems, including performance of self inspections, metrics monitoring and participation in management reviews. 
• Release and rejection authority for products manufactured at the site as well as materials/components used. 
• Ensure appropriate and timely escalation to management for quality related matters. 
• Ensure all personnel are properly trained and qualified to execute their duties
• Ensure appropriate interface with authorities for any GxP and Quality Management System related activity. 
• Conduct periodic management reviews with the Site Leadership Team for process performance, product quality, and the Quality Management System. 
• Participate in the development of Annual Objectives, and ensure implementation, maintenance, and review at the site level. 
• Plan and Manage department budget and establish headcount requirements based upon production plans and regulatory requirements.
• Member of Business Continuity and Alcon Crisis Management (ACM) team as expert for Product Quality role and backup for ACM Director and Coordinator. 
• Responsible for providing a work environment free from recognized hazards and ensure compliance with all applicable laws and regulations.
• Develop the quality organization in terms of knowledge, skill sets and leadership. Prepare development plans for the direct reports to ensure the Quality organization's effectiveness & succession planning through the Talent Management Review processes. 
• Coach / mentor Quality and Site staff including awareness for legal and customers’ requirements.

Minimum Experience:

• Bachelor's degree, Science or Engineering or related Field
• 7 years In medical device/pharmaceutical industry
• Minimum 8 years In a Leadership Position

Preferred Experience:

• Advanced degree, Science, Engineering or related field

ATTENTION: Current Alcon Employee/Contingent Worker

If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.

Find Jobs for Employees

Find Jobs for Contingent Worker

  

Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to alcon.recruitment@alcon.com and let us know the nature of your request and your contact information.

A world empowered by autonomy. We build robotic vehicles to improve logistics safety, forge a greener Earth, and enhance human lives.

We are a closely-knit team aspiring to change the world through disruptive technology. We are innovators. We are tinkerers. We are problem-solvers. And we have a fair amount of magic dust up our sleeves. We have a plan for fleet-level deployment of autonomous vehicles, and we are looking for the best-of-the-best to join us in making this a reality.

About Venti Technologies

Based in the U.S. and Asia, Venti Technologies is the leader in safe-speed autonomous logistics systems, developing the future of goods transportation. Using rigorous mathematics, deep learning, and theoretically-grounded algorithms, Venti has a proprietary collection of autonomy technologies including a suite of powerful logistics algorithms. Venti’s proven value proposition of saving costs, increasing vehicle utilization, and improving safety is recognized by customers and driving growth. Launched in 2018, Venti brings together an unsurpassed team internationally. The company has autonomous systems deployed in Asia for industrial and logistics sites and a growing pipeline. Venti has offices in Cambridge (Massachusetts, USA), Suzhou (China), and Singapore – our Asian headquarters.

Role responsibilities

• To keep abreast of the current state-of-the-art motion control algorithms
• To develop a variety of trajectory tracking algorithms (path and speed profile)
• To account for vehicle dynamics subject to variable loading of towed trailers
• Software design and development

Required experience

• Ideally 1+ years of experience in control research domain.
• Bachelors in computer science, Robotics, or related fields
• Strong familiarity with control systems, robotics, autonomous vehicles
• Strong familiarity with trajectory optimization
• Experience with research in robotics or related fields involving realistic agent motion
• Experience with C++ in a Linux environment
• Flexible problem-solver

Bonus experience

• Experience with ROS or other similar middleware
• Experience with data structures, object-oriented programming
• Experience with real world robotics deployment
• Experience in data-analysis
• Experience in simulation

Salary is commensurate with experience. We also offer world-class benefits, fantastic culture, flexible working arrangements, and a great international working environment. Come and join us!

JOB DESCRIPTION:

• Responsible for day-to-day business data management and regular business report preparations, which includes SAP material master maintenance, data integrity checking and statistics.
• Daily monitoring of basic system health and to flag out any inconsistency in API/System functions when found/reported.
• Daily monitoring of system backend jobs and ensure transactional data are interfacing in healthy state with external/internal system.
• To support Business Analytics, extracting and reorganizing original data, dealing with data related issues with other departments.
• Responsible for data preparation, data mining, to create/identify opportunities through analytics, to optimize business objectives.
• Communicate findings and insights to relevant stakeholders in order to assist Manager in making data-driven decisions in KPI assessments.
• Drive continuous improvements /optimization of campaign performance tracking report with business while complying to A*STAR policies.

REQUIREMENTS:

• Bachelor's Degree or Diploma (with at least 5 years or more relevant experience), preferably Business Analytics, Information systems or Computer Science.
• Strong analytical skills, with experience solving problems using data and providing practical business insights.
• Self-Starter with a strong sense of urgency.
• Aptitude to challenge the status quo, think outside the box, and question what has been done.
• Comfortable with dealing with sets of data points from different sources.
• Qualities of matured thinking, dependable and requires minimum supervision.
• Excellent communication skills (oral and written).

The above eligibility criteria are not exhaustive. A*STAR may include additional selection criteria based on its prevailing recruitment policies. These policies may be amended from time to time without notice. We regret that only shortlisted candidates will be notified.

For more information on working for the Trust, please see the attached Job Description and Person Specification.

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 Summary

This Position Is Responsible For Conducting Data Collection And Abstraction Of Medical Records For Hedis And Quality Projects Including Supplemental Data Collection. Responsible For Interacting With Various Internal Staff, Internal Departments, And Network Providers/Ipa*S To Ensure Quality Performance And Results For Blue Cross Managed Care Products. Responsible For Auditing All Aspects Of Bcbsil Clinical Quality Improvement Projects And Evaluating Pcp/Mg/Ipa Compliance With Bcbsil Clinical Practice Guidelines. Also Responsible For Data Analysis, Interaction With Providers* Practices And Ipas To Educate On Hedis Measures, Gaps In Care And Quality Programs. Translate Data Into Actionable Information And Determine Areas For Improvements As Well As Help Implement Actions Toward Improvement And Report Results To Internal And External Customers.

Required Job Qualifications:
*Registered Nurse (RN) OR licensed clinician with current, unrestricted license in Illinois
*Minimum of 3 years of clinical practice experience performing HEDIS medical record review
*Minimum of 3 years of Healthcare or Managed Care experience, including quality improvement and/or project management experience
*Minimum of 1 year HEDIS medical record data abstraction
*Data analysis experience, skills and knowledge of statistical analysis software, and statistical methods and meaning knowledge
*Ability to adapt to changing priorities and managing a wide range of quality projects
*Able and willing to travel
*Verbal and written communication skills
*Problem resolution skills and ability to work with difficult situations with respect and diplomacy
*Presentation planning and delivery experience for provider training

Preferred Job Qualifications:
*Working knowledge of managed care programs and NCQA and/or URAC Accreditation guidelines
*Project management experience and skills

This is a flex position, requires some days in office/ some days work from home

This role is based in Chicago IL

Are you being referred to one of our roles? If so, ask your connection at HCSC about our Employee Referral process!

HCSC Employment Statement:

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.

The Role

The Compliance Specialist is responsible to ensure the Company complies with external regulations, legal requirements and its internal policies. He/she will work closely with various stakeholders to identify risk areas and implement effective compliance policies and procedures.

Job Responsibilities

Audit

• Facilitate and support communications with internal/external audit in collaboration with respective departments
• Provide guidance to staff on managing requests from auditors
• Review adequacy of audit submissions by departments
• Follow up audit findings and lessons learnt from External and Internal Audit

Corporate Policy and Procedure

• Provide an independent oversight and observation
• Facilitate regular reviews of policy and procedure for alignment with regulatory requirements and implement best practices.
• Facilitate adoption of policy and procedure by departments

Training, Assessment and Monitoring

• Conduct and provide training on external regulations and relevant policies
• Ensure that all required trainings and due diligence checks are completed within schedule and maintain training records
• Evaluate and examine whether the activities performed by Business Units are effective, appropriate and compliant with key regulations
• Monitor expiry of any certificate, license and registration and ensure timely renewal
• Participate and provide support in compliance investigations
• Initiate and support Annual System Risk Assessments with respective System Managers and follow up on any identified risks for mitigation and closure.
• Initiate regular BCP tests and follow up actions

Handling Regulatory Related Matters

• Identify applicable laws and regulatory requirements
• Keep abreast of regulatory changes/updates and perform gap analysis for alignment of entity policy and procedures as needed
• Review and assess breaches flagged to compliance

Others

• Support Team Lead in providing guidance stakeholders on compliance matters
• Perform other duties as and when assigned

Job Requirements

• Bachelor’s Degree in Law, Business Administration, Finance, Accounting, Information Systems or related field.
• Min. 3 years of relevant work experience in compliance, internal control, risk management or internal audit.
• Preferably with professional certifications such as CISA, CISM, CISSP, CIPP, CBCI, CRM, ICA, CA).
• Possess a strong understanding of Singapore laws, regulations (including MAS guidelines and notices) and relevant industry standards such as information processing and financial industries
• Preferably with working experience in financial services, IT industry in particular related to system development and integration
• Preferably with IT audit experience.
• Excellent technical writing and documentation skills
• Advanced skills in using Microsoft Office products
• Good appreciation for risk related subjects
• Strong communication, interpersonal and presentation skills
• Possess excellent analytical skills, attention to detail to ensure quality of deliverables
• Experience in operating and maintaining Crisis Notification System
• Effective communication and management of stakeholders
• A self-starter team player who can work proactively with minimum supervision
• Ability to multi-task, work under pressure and meet tight deadlines
• High level of integrity and takes accountability over work

The Role

The Compliance Lead will ensure the Company complies with external regulations, legal requirements and its internal policies. He/she will lead the compliance program in collaboration with various stakeholders to strengthen the Company’s processes.

Job Responsibilities

Audit

• Lead communications with external/internal audit in collaboration with respective departments
• Provide guidance to staff on managing requests from auditors
• Review adequacy of audit submissions by departments
• Plan for any mitigation controls with relevant departments and track the implementation to closure for reporting to management

Corporate Policy and Procedure

• Define and review internal compliance policy and procedure to incorporate industry best practices to strengthen governance for corporate risks
• Develop risk management strategies
• Regularly review and revise Business Continuity Plans (BCP)
• Provide an independent oversight and propose solutions to address problem/inadequate areas
• Spearhead and drive adoption of policy and procedure by departments

Training, Assessment and Monitoring

• Ensure that all required trainings and due diligence checks are conducted and completed within schedule
• Evaluate and examine whether the activities performed by Business Units are effective, appropriate and compliant with key regulations
• Report the results of evaluation and examination to Management
• Lead compliance investigations and ensure that it is conducted as per the approved processes
• Plan for Annual System Risk Assessments with respective System Managers and follow up on any identified risks for mitigation and closure

Handling Regulatory Related Matters

• Keep abreast of regulatory changes/updates and perform gap analysis for alignment of entity policy and procedure as needed.
• Review and assess breaches flagged to compliance

People Management and Others

• Manage and oversee the day-to-day operations of the compliance team and provide guidance where necessary
• Perform other duties as and when assigned

Job Requirements

• Bachelor’s Degree in Law, Business Administration, Finance, Accounting, Information Systems or related field.
• Min. 5 - 8 years of relevant work experience in compliance, internal control, risk management or internal audit in a bank, financial institution or audit firm.
• Preferably with professional certifications such as CISA, CISM, CISSP, CIPP, CBCI, CRM, ICA, CA).
• Possess in-depth knowledge of Singapore laws, regulations (e.g. MAS Notices and Guidelines including but limited to TRM, Guidelines on Outsourcing Risk Management, Guidelines on Business Continuity Management
• Preferably with working experience in financial services, IT industry in particular related to system development and integration.
• Preferably with IT audit experience.
• Excellent technical writing and documentation skills
• Advanced skills in using Microsoft Office products
• Good appreciation for risk related subjects · Strong communication, interpersonal and presentation skills
• Possess excellent analytical skills, attention to detail, and the ability to interpret complex regulations.
• Experience in operating and maintaining Crisis Notification System
• Effective communication and management of stakeholders
• A self-starter team player who can work proactively with minimum supervision
• High level of integrity and takes accountability over work
• Ability to generate innovative ideas and challenge the status quo