Quality Assurance Manager, Quality Systems Greater Boston HybridPosition Overview The Quality Assurance Manager, Quality Systems will own, develop, and execute the entire Quality process for this growing CMO! The Quality Assurance Manager, Quality Systems will serve as a key point of contact for the company's QMS, maintain compliant GMP and non-GMP documentation in support of various Quality Systems, and serve as a Subject Matter Expert (SME) in multiple areas of Quality. Responsibilities
- Review and approve records through the Electronic Document Management System (eQMS)
- Schedule, manage and perform internal and external audits.
- Review of master batch records, executed batch records, and other quality records.
- Provide mentorship, guidance, and training to Quality and other GXP compliant personnel.
Support Implementation and management of various QMS elements including a purchasing controls program by developing and implementing SOPs for purchasing controls, materials management, supplier management, and quality technical agreements.
Conduct and follow-up on audits as appropriate
Deviations, CAPAs, Change Control, and the maintenance of the lot genealogy system.
Provide flexible and novel approaches to Quality processes to start-up the company's internal programs.
- B.A./B.S. degree in a business or life sciences related field
- 5+ years combined Quality organization experience.
- Experience in cGMP environment in pharmaceutical/biologics. Cell and gene therapy is a plus.
- Experience with GMP/Google Cloud Platform/ICH standards and regulatory guidance documents.