Quality Systems Supervisor, Site Quality Assurance Operations
Editas Medicine
- Waltham, MA
- Permanent
- Full-time
- Support Editas’ clinical cell manufacturing facilities in Waltham, MA and Devens, MA as a member of the Quality Operations team with primary focus on QMS records and technical reviews related to both Manufacturing and Quality Control.
- Provide Quality oversight of start-up activities for a new facility and equipment as well as process commissioning & qualifications.
- Review and approve deviations, change controls and CAPAs for appropriateness, completeness and to meet internal procedures and regulatory expectations.
- Author, review and/or approve GMP documentation (SOPs, batch records, protocols, technical reports, test methods, protocols, specifications, and summary reports to support GMP manufacturing and QC testing).
- Support QA on the floor activities including line clearance and QA process touchpoints as required.
- Establish, implement, maintain, improve, monitor and report on quality and compliance systems including management, review, or performance of associated trending.
- Build and manage a small team of Quality Engineers/Specialists
- Train and mentor other Quality staff
- Support clinical lot disposition activities as needed.
- Work collaboratively with cross functional teams, partners, and vendors to gather background knowledge needed to complete assignments.
- Independently review, manage, and/or perform complex investigations in cross-functional areas.
- Exercise good judgment in issue identification, resolving moderate to complex quality issues, and escalations.
- Act as QA liaison to site personnel to provide quality system expertise to help identify solutions and ensure compliance to cGMP
- Plan and execute work independently with management consultation as needed.
- Supports the organization in maintaining inspection readiness.
- Provide QA oversight for product Shipments
- Assist in internal and external audits as required.
- Experience supporting cGMP biologics manufacturing required. Experience with both early and late phase clinical manufacturing preferred. Experience with new product introductions or facility start-ups preferred. Experience providing quality oversight for QC strongly preferred.
- A working knowledge of cGMP requirements in clinical or commercial biologics required. Experience in both clinical and commercial or late stage clinical preferred. Experience with mammalian cells and/or gene therapies preferred.
- Experience leading and managing a team.
- Excellent verbal and written communication skills including technical writing required.
- Expertise performing/assessing root cause analysis investigations required. Expertise performing/reviewing laboratory investigations strongly preferred.
- Demonstrated expertise understanding/interpreting regulatory guidance on cell and gene therapy products required.
- Strong communicator and collaborator who possesses a flexible approach to problem solving and ability to apply risk-based decision making
- Proven ability to work independently as well as to collaborate with peers and work effectively in a team-oriented environment; highly organized.
- Ability to manage multiple projects with minimal oversight in and evolving environment
- B.S., M.S., or PhD in a scientific discipline with 10+ years of experience as a Quality professional in the biopharmaceutical industry
- An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
- Ability to gown into a cleanroom
- Ability to support a morning or evening shift schedule.
- Some travel may be necessary