Associate Director, Quality Control Raw Materials

Job Description

General Summary:

The Associate Director of QC Raw Materials manages and directs the Vertex cell and gene therapy raw materials team. This position will provide leadership and technical expertise in Quality Control Raw Materials Program Management. The role is responsible for leading other QC personnel, optimizing Department resource allocation according to project/program needs to assure testing activities occur in an efficient and cGMP compliant manner while fostering the Vertex vision and values

Key Responsibilities

• Develop and execute the QC Raw Materials program strategy for in-house manufacturing of Vertex Cell and Genetic Therapies. This position requires strong partnerships with process development(PD), Supply Chain and Materials Management, Quality Control and Quality Assurance.
• Develop and lead a high-performing team, facilitating goal setting and development of direct reports.
• Manage relationships with outside stakeholders to ensure QC testing is performed and results are provided to Vertex standards
• Manage raw material control program across sites
• Support internal and external audits, inspections and technology transfers as required.
• Initiate and provide support and guidance for the resolution of investigations, deviations, CAPAs, change controls, and other quality systems issues, as appropriate
• Lead training sessions on QC Raw Material owned procedures to QC staff and external groups, as needed.
• Support vendor evaluation and associated contracting diligence in conjunction with Supplier Management and Quality Assurance.
• Proactively pursue continual improvement and procedural changes

Knowledge and Skills:

• Proven track record of building and managing the day-to-day operations of a QC Raw Materials group
• Demonstrated knowledge of agency requirements for Raw Materials
• Ability to interface effectively with management and other groups, project teams and personnel at manufacturing site
• Excellent leadership skills to lead cross functional teams to ensure project success
• Excellent interpersonal skills with ability to handle conflict effectively.

Education and Experience:

• M.S. or B.S. with a minimum of 10 year's experience in a cGMP Quality Control lab and 6 years in a managerial role; or equivalent combination of education and experience.
• Experience in Raw Materials Quality Control for cell therapy or related products
• Experience managing a raw materials control program in clinical and/or commercial setting

Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

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