Associate Director, GMP Quality Assurance
Reports to: Head of Quality Assurance
Location: Princeton, NJ
This role is responsible for providing GMP QA expertise and oversight of contract manufacturing vendors supporting investigational and commercial product for PMV Pharma. The successful candidate will also have IT QA experience to support QA activities involving internal and external GxP software and systems supporting PMV Pharma.
- Provide GMP QA leadership and support to PMV’s CMC, API, drug product, and supply chain/logistics operations related to all GMP contract manufacturing organizations utilized by PMV as clinical trial material.
- Provide GMP expertise and QA support to the development of the commercial supply chain and ensuring inspection readiness.
- Ensure all API, drug product and investigational product batches are released on time.
- Review and approve of Master Batch Records and executed batched records.
- Ensure all labelling and packaging components are approved and released on time for use.
- Provide quality assurance oversight of software development and validation lifecycle activities associated with regulated computerized systems to ensure conformance to cGxPs.
- Oversee key software development life cycle (SDLC) processes such as change control, release, deviations, etc.
- Review and approve validation deliverables associated with various PMV systems such as clinical study databases electronic Case Report Forms (eCRF) and Interactive Response Technologies (IRT), Quality Management Systems (QMS) and Learning Management Systems (LMS)
- Conduct audits of vendors specifically supporting GMP activities or utilizing computerized systems in support of GxP activities e.g., GLP, GCP, GPV.
- BS - in Life Sciences, Engineering, or IT related discipline.
- 5+ years of experience GMP regulated industry, preferably biotech or pharmaceutical.
- 2+ years’ experience working in or supporting an IT Quality role - preferred.
- In depth knowledge of GMP regulations, quality systems, quality assurance, quality control, conduct of quality audits.
- Solid understanding of GxP guidance, including 21 CFR Part 11, Annex 11, and data integrity experience with computer system validation across GxPs.
- Knowledge of the IT system development life cycle and software quality assurance in a regulated environment
- Knowledge of general networking concepts and IT best practices.
PMV provides a competitive benefits package that includes a choice of employee covered medical health, dental, and vision insurance; life insurance, flexible spending accounts, 401K plan, Employee Stock Purchase Plan, generous PTO, and stock options.
How to Apply
To apply, please submit your cover letter and resume to Recruiting@pmvpharma.com.
PLEASE, NO PHONE CALLS or AGENCIES
PMV Pharmaceuticals is an Equal Opportunity Employer and all applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.