Manager, QA Compliance

The Manager of QA Compliance, reporting to the Director, QA Compliance, responsible for the development, review, execution, and maintenance of the Quality Agreement.  Support internal and external audit operations, inspection readiness, and compliance metrics. This role requires strong cross-functional collaboration with CMC, Quality Control, Supply Chain Management, Regulatory Affairs, Legal, Contract Service Providers, and other functional areas as needed.

• →Lead and manage global Quality Agreements/QTAs by developing, reviewing, executing, and maintaining agreements, ensuring compliance with the scope of services, regulatory requirements, internal standards, and all terms and conditions
• →Collaborate with internal cross-functional teams and external stakeholders (e.g., contract service providers) to bring Quality Agreements to an approvable state
• →Track Quality Agreement renewal and revision cycles
• →Support regulatory authority inspection readiness activities at CSP and internally
• →Participate in the global supply chain vendor qualification process to ensure compliance with regulatory and internal standards
• →Participate in the planning of internal audits
• →Ensure audit findings are followed up on, corrective actions are completed, implemented, and verified to ensure compliance
• →Identify and assess risks to compliance, develop mitigation strategies, and ensure effective implementation
• →Maintain master vendor list with up-to-date Health Authority certification/licenses
• →Maintain risk registers and communicate risk trends to Quality leadership
• →Develop, track, analyze, and present Quality Compliance metrics, including audit data, CAPA performance, Quality Agreement KPIs, risk assessments, and vendor performance indicators
• →Prepare quality dashboards and monthly/quarterly reports for management review
• →Support SOP development and revision related to Quality Agreements, auditing, risk management, and metrics
• →Other duties as assigned

This is a U.S.-based remote role that will require quarterly, or as needed visits to our San Francisco Office.

• Bachelor's degree in a scientific discipline; an advanced degree is a plus
• A minimum of 8+ years of experience working in a Biotech or Pharmaceutical FDA-regulated industry in QA or a related field, or an equivalent combination of education, training, and/or experience from which comparable knowledge, skills, and abilities have been attained
• Hands-on experience drafting commercial Quality Agreements with various scopes of services
• Prior experience in vendor qualification processes
• Excellent communication, relationship-building, and technical writing skills
• Strong knowledge of global GxP regulations (FDA, EMA, ICH)
• Prior experience in leading/supporting PAI readiness activities
• Ability to work in a virtual environment
• Ability to thrive in a dynamic, fast‑paced, cross‑functional environment
• Willingness to travel both domestically and internationally as required

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