Senior Manager, Clinical Quality Assurance

Responsibilities:
- Support assigned clinical studies as a core team member (study meetings, document review, GCP-related QA consultation).
- Identify and escalate serious non-compliance issues, including assessment of serious breaches.
- Serve as Clinical QA point of contact for clinical functional areas (study and non-study projects).
- Support management of study-specific deviations/events/CAPAs (GCP/PV).
- Collaborate with CRO quality counterparts (incl. QA-QA meetings).
- Lead/participate in internal and external GCP audits (planning, agendas, execution, reports, responses/clarifications, CAPA issuance, audit closing).
- Maintain audit results in Veeva Quality Vault (preferred) and report compliance trends.
- Present audit findings to appropriate personnel and work with auditees to complete CAPAs.
- Support partner audits and regulatory inspections; participate in inspection readiness and pre-approval preparations.
- Support quality/compliance process improvement initiatives.
- Support investigator site audits.

Qualifications:
- BS/BA in a relevant discipline (Biological/Life Sciences preferred).
- 6+ years in pharmaceutical drug development in Clinical Quality Assurance and/or GCP-related discipline.
- Quality Auditor/Manager certification preferred.
- Strong knowledge of ICH GCP and domestic/international GCP regulations.
- Experience leading audits of GCP/GCLP/GPvP vendors and investigator sites; internal functional/process audits.
- Experience with inspection readiness and supporting FDA/EMA and other health authority inspections.
- Ability to build cross-functional relationships; self-directed, initiative-taking; excellent customer service.
- Excellent oral and written communication.

Compensation/Benefits (as stated): $165,000–$180,000 USD annually; stock programs, performance-based bonus, and comprehensive benefits package.

Location: Hayward, CA (preferred) or remote.