Job Description
Our client is seeking an Interim Quality Management System (QMS) Operations Lead to support quality operations for a Bay Area–based pharmaceutical/biotech team. The ideal candidate brings deep hands-on experience owning and operating pharmaceutical or biotech QMS processes, with a strong command of GxP (GMP, GDP, GCP), deviations/CAPA, audits, and controlled documentation. This role requires a proactive, collaborative leader who can partner cross-functionally and provide day-to-day QMS oversight within a lean quality organization.
Key Responsibilities
- Serve as day-to-day owner of QMS operations and ensure consistent execution, documentation, and oversight across teams.
- Manage deviation handling, root cause analysis, CAPA, and change control processes.
- Lead preparation for internal and external audits; support audit execution, follow-up, and responses to findings.
- Maintain and improve procedural documents, including authoring, reviewing, and updating SOPs and quality policies.
- Partner with cross-functional stakeholders, including QA, operations, supply chain, and regulatory, to ensure compliance and QMS effectiveness.
- Coordinate closely with the East Coast QMS Operations team to align standards, processes, and documentation.
Qualifications
- 8–15+ years of pharmaceutical or biotech industry experience with direct, hands-on ownership of QMS processes.
- Strong knowledge of GxP requirements (GMP, GDP, GCP) within a regulated environment.
- Proven experience with deviations, CAPA, change control, and audit preparation/management.
- Demonstrated ability to work in hybrid hands-on/leadership roles within lean QA or quality systems teams.
- Preferred certifications (not required): ASQ Certified Quality Auditor (CQA) or similar.
Start: Target January 2025 (client exploring earlier start)
Duration: Initial 3-month engagement, with likely extension
Time Commitment: Full-time, 5 days/week
Location: Hybrid – remote with on-site work in San Francisco/San Jose a few days/week
Expected Candidate Rate: $110 – $125/hour
Project ID#: 8132
*This is a 1099 contract role that does not offer health benefits