Quality Assurance Manager
Responsibilities of the Quality Assurance Manager:
- Lead and manage a Quality Operations team supporting clinical cell manufacturing facility
- Provide Quality oversight of tech transfer and new cleanroom start-up for new investigational products
- Author, review and approve GMP documentation (SOPs, batch records, protocols, technical reports, test methods, protocols, specifications, and summary reports to support GMP manufacturing).
- Review and approve deviations, change controls and CAPAs for appropriateness, completeness and to meet internal procedures and regulatory expectations.
- Work collaboratively with cross functional teams, partners, and vendors to gather background knowledge needed to complete assignments.
- Coordinate activities for equipment qualification and collaborate on the development of process documentation.
- Establish, implement, maintain, improve, monitor and report on quality and compliance systems.
- Aid PD and Manufacturing staff with BOM creation and materials risk assessments.
- Exercises judgment in resolving moderate to complex quality issues and escalates issues as appropriate.
- Assist in internal audits to ensure compliance to quality system requirements and product specifications.
- Train and mentor other Quality staff
Requirements of the Quality Assurance Manager:
- B.S., M.S., or PhD in a scientific discipline with 10+ years of experience as a Quality professional in the biopharmaceutical industry
- Extensive experience managing Quality Operations or Quality Systems.
- Experience leading and managing a team.
- Excellent verbal and written communication skills.
- Proven ability to work independently as well as to collaborate with peers and work effectively in a team-oriented environment; highly organized.
- Experience supporting Quality Operations required. Experience with both early and late phase clinical manufacturing preferred.
- Experience with new product introductions or facility start-ups preferred.
- A working knowledge of GMP requirements for Clinical Trial Material in both the US and EU including sterile manufacturing strongly preferred.
Commonwealth Sciences is a professional recruiting firm specializing in Life Science, Medical Device, and Engineering Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.