Manager, QA Operations

What You'll Do

The Manager/Senior Manager, QA Operations will serve as the primary quality owner for commercial packaging operations at assigned contract service providers (CSPs). You will ensure GMP compliance across day-to-day operations, manage batch record review and disposition activities, and serve as the quality partner to internal and external stakeholders. The ideal candidate brings expertise in commercial packaging and release operations, with a background that includes process validation and product launch support.

Responsibilities

• Serve as the quality lead for commercial packaging operations at assigned CSPs, providing oversight across primary/secondary packaging, labeling, and serialization to ensure GMP and GDP compliance.

• Review executed batch records and compile batch documentation packages to support lot disposition and market release.

• Provide quality review of deviations, change controls, CAPAs, and risk assessments related to packaging operations.

• Review and provide quality input on tech transfer, process validation, and shipping qualification protocols and reports through preparation, execution, and closure.

• Communicate/escalate manufacturing deficiencies/non-conformances to management, present issues during escalation, and work with CMOs to ensure timely resolution

• Support review of CMC sections and regulatory filings.

• Author, review, and maintain QA Operations SOPs and controlled documents.

Where You'll Work

This is a hybrid role and requires in-office collaboration 2-3x per week in our San Francisco Office or a U.S.-based remote role that will require quarterly, or as needed visits to our San Francisco Office.

Who You Are

• Bachelor’s degree in a scientific discipline with 6+ years of experience within a biopharmaceutical company and at least 4+ years in Quality Operation roles in a current Good Manufacturing Practices (cGMP) environment.

• Strong working knowledge of FDA regulations (21CFR, 210/211), ICH guidelines, and global regulations (EU Directives, and ROW) and expertise in the cGMP requirements pertaining to manufacturing and packaging operations (including serialization) in the United States and globally in support of global commercial production activities.

• Experience with Veeva platform highly preferred.

• Strong communication and collaboration skills with the ability to influence stakeholders in a matrix environment.

• Ability to exercise good judgment and make decisions that align with organizational objectives.

• Results-driven mindset, taking initiative and ownership of assigned tasks.

• Demonstrated flexibility and adaptability in a dynamic, rapidly growing environment.

• Commitment to continuous improvement and embracing innovative approaches in daily work.

• Up to 15% domestic and international travel required.