QMS Operations Lead – Pharma / Biotech

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

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