Quality Assurance Manager

As the founding QA leader for our U.S. operations, you will build, implement, and lead the Quality Management System supporting cell line development (CLD), cell culture process development, and small-scale powder/liquid media production. This is a hands‑on leadership role responsible for establishing scalable quality systems, overseeing core QA functions including document control, deviations/CAPA, batch record review, supplier quality, and lot release, and driving the site's progression toward GMP readiness as operations expand.

• Own facility operations for the Pleasanton site, including labs, clean rooms, warehouse, cold storage, utilities, and support spaces.
• Manage preventive maintenance, calibration coordination, work orders, spare parts, and service contracts for facility and utility systems.
• Oversee site utilities including HVAC/BMS/EMS interfaces, CDA, vacuum, RO/DI, gases, cold rooms, freezers, LN2 systems, and emergency response readiness.
• Partner with QA, QC, Production, and EHS to maintain facility compliance, environmental readiness, and inspection preparedness.
• Support equipment move‑in, installation, commissioning, verification, and startup activities for new and relocated equipment.
• Act as primary on‑site contact for landlords, contractors, service vendors, and selected local authorities for facility‑related matters.
• Lead change control, CAPA support, deviation follow‑up, and root cause investigations related to facility and utility issues.
• Develop and maintain SOPs, PM programs, logbooks, alarm escalation workflows, and facility records.
• Drive cleanroom and controlled‑area housekeeping standards with internal teams and external cleaning vendors.
• Build and manage facility budgets for maintenance, repairs, small capital projects, and operating supplies.
• Identify reliability risks early and implement practical solutions that reduce downtime and protect startup timelines.

• Bachelor’s degree in engineering, facilities, life sciences, or a related field; equivalent practical experience may be considered.
• 7+ years of relevant experience in biotech, pharma, diagnostics, medical device, or other regulated technical environments.
• Hands‑on experience supporting labs, clean rooms, utilities, and vendor‑managed maintenance programs.
• Strong working knowledge of HVAC, pressure cascades, utilities, alarms, and building systems in GMP or GMP‑like settings.
• Experience with startup, expansion, commissioning, or major facility improvements is strongly preferred.
• Able to balance technical detail with execution speed in a small, fast‑moving organization.

• Experience supporting media, biologics, cell culture, or related manufacturing / development operations.
• Familiarity with calibration / metrology programs, EMS/BMS, and contractor oversight.
• Working knowledge of EHS, biosafety, hazardous materials, and waste handling requirements in California.

• Able to move throughout lab, warehouse, and utility areas daily.
• Able to lift up to 25 lbs occasionally and support equipment / vendor walkthroughs as needed.
• Available for occasional off‑hours support during alarms, maintenance windows, or startup events.

This job description is intended to describe the general scope of the role. Responsibilities may evolve as the Pleasanton site ramps and organizational needs change.