Senior Manager, Quality Control Operations

Company: Vertex Pharmaceuticals Inc (US)
Location: Cambridge
Posted on: May 3, 2021

Job Description:

In June 2019, Vertex announced the establishment of a new research site in the Boston area where research, development, and clinical manufacturing for cell and genetic therapies will be primarily based. Cell and genetic therapies represent two rapidly emerging therapeutic modalities with the potential to treat—and even cure—several of the diseases Vertex is focused on, including sickle cell disease, Duchenne muscular dystrophy and type 1 diabetes. Further investment in a research site specifically designed to advance these programs will be key to Vertex’s continued and sustained leadership in these exciting approaches. At Vertex Cell and Genetic Therapies (VCGT) our research teams bring together the best biology, technologies and enhanced manufacturing capabilities to ensure we bring these cutting-edge transformative therapies to patients as quickly as possible. 

We are looking for a proactive, and technically knowledgeable candidate to be Sr. Manager, Quality Control Operations to support VCGT cell therapies programs. This position will provide leadership and technical expertise in Quality Control operations.

Key Responsibilities

• Collaborate with outside stakeholders to ensure QC instrumentation is procured and maintained to GMP standards

• Develop and lead a high-performing team; facilitating goal setting and development of direct reports.

• Ensure that the QC lab is maintained to GMP housekeeping standards and according to EH&S and that all analysts are trained on this activity

• Maintain inventory of plastic consumables, reagents, controls and ref standards; track expiry of all QC consumables

• Proactively pursue continual improvement and procedural changes

• Liaise with stakeholders to determine testing and shipping logistics

• Develop and Execute on QC Operational strategy in conjunction with QC analytical and senior leadership.

• Support internal and external audits, inspections and technology transfers as required.

• 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 Lab Op owned procedures to QC staff and external groups, as needed.

• In collaboration with key stakeholders, oversee external vendors/contract testing facilities

• Conduct vendor evaluation and associated contracting diligence

?Knowledge and Skills:

• Proven track record of building and managing the day-to-day operations of a QC group

• In-depth knowledge of ICH guidelines, GMP and ISO requirements for aseptic manufacture of clinical material.

• Experience executing and validating analytical test methods (FTIR, flow cytometry, qPCR, cell counting, ELISA, cell-based bioassays, etc)

• 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 8 year’s experience in a cGMP Quality Control lab and 4 years in a managerial role; or equivalent combination of education and experience.

• Experience in Quality Control for a cell therapy

• Experience managing a raw materials control program preferred.

Keywords: Vertex Pharmaceuticals Inc (US), Cambridge , Senior Manager, Quality Control Operations, Other , Cambridge, Massachusetts