Senior Manager, QA Operations

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. 

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:

• Bachelor’s degree with 10 years or Master’s degree with 7 years of experience in a GMP-regulated biopharma/biotech environment.
• Expertise in supplier/vendor quality management, biologics quality assurance, and regulatory compliance (FDA, ICH, GMP standards).
• Proven skills in GMP documentation, risk analysis, project management, and cross-functional collaboration.
• Strong problem-solving, communication, and organizational abilities, with a focus on adapting to dynamic environments.
• Preferred skills include root cause analysis, operational excellence qualifications, and availability for up to 25% travel.