What are the responsibilities and job description for the Senior Manager, QA Operations position at Meet?
We are partnered with a growing biotech organization that is seeking a Bay Area-based Senior Manager of QA Operations. This role is focused on providing quality oversight and decision making regarding the starting material and drug substance development and manufacturing at the CDMO. This is a great opportunity for someone who is interested in creating therapeutics for serious autoimmune and cancer indications, which are in clinical trials. This role is ideally seeking candidates who are based in the Bay Area and will work remotely with expected travel.
Responsibilities :
- Oversee quality-related activities at CDMOs, including cell banking, stability programs, manufacturing, testing, and process development.
- Manage quality systems at CDMOs, such as deviations, CAPAs, complaints, and batch release, ensuring compliance with standards.
- Conduct and review quality documentation, including SOPs, batch records, analytical methods, and regulatory submissions.
- Collaborate with CDMOs and internal teams to address quality issues, ensuring products meet quality standards and specifications.
- Monitor and report quality metrics, perform risk assessments, and maintain readiness for audits and regulatory inspections.
Requirements :
Contact :
For a confidential discussion, please reach out to Amit at amit.uma@meetlifesciences.com or 628 336 2772.
