Director, Global Microbiology Governance & Oversight

Job overview

The Director, Global Microbiology Governance & Oversight role is onsite in San Mateo, CA; compensation is not specified. The role supports product safety, purity, and efficacy across biopharmaceutical manufacturing facilities. The Director establishes global microbiology standards and contamination-control governance, aligning laboratory operations with regulatory requirements. The role harmonizes practices across sites, leads complex investigations and corrective actions, and provides microbiology expertise for facilities, technology transfers, and product introductions.

What you'll do

• Provide global leadership for contamination-control strategy and consistent implementation
• ensure adherence to FDA, EMA, cGMP, and USP/EP standards and serve as a subject matter expert during inspections and audits
• establish standards for microbial limits, sterility, endotoxin, and bioburden testing
• harmonize microbiology practices
• lead high-risk investigations, root-cause analysis, and CAPA
• identify microbiological and regulatory risks
• build a global microbiology community
• advise on facilities, technology transfers, capital projects, and product introductions
• partner with Manufacturing, R&D, and Engineering on risk assessments
• lead technology implementation and operational excellence projects. Travel up to 20%.

What we're looking for

Skills & competencies

director

global microbiology

governance

contamination control

environmental monitoring

sterility testing

bioburden

cgmp

lims

san mateo ca

beone medicines

biopharmaceutical manufacturing

Work arrangement

• Weekend coverage required

Why this role

Global microbiology governance across manufacturing sites, including contamination control, environmental monitoring, and laboratory systems.

About the employer

BeOne Medicines is hiring for this role. Industry: Pharmaceutical Preparation Manufacturing. Sector: 32.