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Manager, GMP Quality Assurance - Princeton, United States - PMV Pharmaceuticals Inc
1 week ago
Description
Manager, GMP Quality Assurance - ContractorReports to:
Associate Director, GMP Quality Assurance
Location:
Princeton, NJ, Hybrid
This contracting role is responsible for providing GMP QA expertise, oversight and auditing support of contract manufacturing organizations supplying current investigational (and future commercial) products for PMV Pharma.
Responsibilities
Support GMP QA activities spanning across CMC (Chemistry, Manufacturing & Controls) for API and drug product, and supply chain/logistics operations, for all outsourced GMP clinical trial material manufacturing.
Ensure all API, drug product and packaged and labelled investigational product batches meet GMP regulations, as applicable to phase of development, and are released on time.
Review and approve master batch records, executed batch records, material specifications, and analytical documents.Maintain GMP electronic document files in an organized and compliant manner.
Provide GMP QA expertise to the development of the commercial supply chain and ensure inspection readiness.
Support the development / amendment of Quality Assurance Agreements with GMP vendors and key raw material suppliers.
Support risk based management activities including change control, deviation and CAPA management and the generation of quality metrics as needed.
Lead and support audits and associated vendor audit plans specifically supporting GMP activities.Review CMC sections of regulatory filings to ensure consistency with applicable GMP regulated activities.
Support regulatory inspectional activities including at PMV and GMP contract manufacturing sites.
Up to 10% Travel / Field work is required to domestic and international locations in a lead / support role with consultants, partners, subject matter experts, inspectors, etc.
Support the creation and management of GxP SOPs throughout the PMV organization, and the execution of the GxP training program.
Provide support to QMS system activities including system security, access, upload and computer validation activities as needed.Qualifications
Bachelor's degree in Life Sciences, Engineering, or related discipline.
Minimum of 3 years of experience in a GMP regulated industry, preferably biotech or pharmaceutical, performing quality assurance functions. Experience with solid dosage forms preferred.
Experience in QA oversight of global GMP contract manufacturing organizations preferred.
In-depth knowledge of GMP regulations, quality systems, quality assurance, quality control, conduct of quality audits.
Experience in the use of electronic quality management systems (eQMS) such as Veeva (Veeva preferred) Trackwise or, MasterControl.
Knowledge of risk management approaches in clinical phase and commercial manufacturing.
Ability to work both independently with minimal direction and within project teams, supporting multiple projects simultaneously.
Strong verbal / written communication and presentation skills.
Ability to work well in a deadline-driven environment.
Excellent computer skills in use of Microsoft Office (Excel, Word, PowerPoint); experience with project management software (Microsoft Project, Visio, etc) preferred.
How to ApplyTo apply, please submit your cover letter and resume to or apply through our Online Portal .
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.
