Associate Director, Quality Technical Compliance

1 week ago

Boston, United States Vertex Pharmaceuticals Incorporated Full time

Job Description

General Summary:

The Associate Director, Quality Technical Compliance provides technical and strategic leadership for quality systems, inspection readiness, risk management, and quality culture. This position focuses not just on the "what" but the "how", ensuring phase appropriate quality compliance.

Key Duties and Responsibilities:

  • Facilitate and support CDMO/CMO, Vertex site, and country office inspections across the VCGT network.
  • Manage inspection readiness and internal site audit logistics.
  • Maintain the Inspection Management Gateway content (SharePoint), Inspection Hub, and resource Tool kit for all inspections per forecast.
  • Lead and participate in site walkthroughs assessing facility, process, and product issues/risks.
  • Review inspection responses and coordinate response committee actions for observation management with the key stakeholders and external partners.
  • Coordinate risk reviews with VCGT Quality Systems and Compliance and internal stakeholders.
  • Lead and participate in continuous improvement projects.
  • Provide technical and strategic support to functional areas including other quality groups for change controls, deviations, qualification, and risk assessments.
  • Participate in cross-functional projects in a Quality expert and leader role.
  • Identify and facilitate resolution of technical issues in partnership with QA Operations.
  • Support inspection readiness by providing strategic and technical guidance and coaching to both internal and external personnel.

Knowledge and Skills:

  • Expert knowledge of global GMP requirements governing CGT products.
  • Ability to evaluate quality matters and make decisions utilizing a risk-based approach.
  • Strong technical knowledge including but not limited to: Aseptic practices, auditing techniques, facility design, and QMS design.
  • Solid quality culture knowledge and understanding of how to influence and improve overall compliance.
  • Superb facilitation, communication, and coaching/influencing skills with proven ability to lead teams.
  • Broad knowledge across multiple GxP areas.
  • Proven ability to identify and analyze performance indicators.

Education and Experience:

  • Bachelor's degree in a scientific discipline, operations research, operations management, or a related field.
  • Typically requires 8 years of experience or the equivalent combination of education and experience.

Work Arrangement:

This is a Hybrid or On-Site-Eligible role, where you can choose to work:

  1. On-Site: work 5 days per week with ad hoc flexibility.
  2. Hybrid: work remotely up to two days per week on regularly scheduled days.

Flex Designation: Hybrid-Eligible or On-Site Eligible.

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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