Director, Global Microbiology Governance & Oversight

BeiGene

3d•$168,000 - $228,000

About The Position

The Director, Global Microbiology Governance & Oversight ensures the safety, purity, and efficacy of biopharmaceutical products by overseeing contamination control strategies, environmental monitoring programs, and microbial identification systems across manufacturing facilities. The role aligns laboratory operations with global regulatory standards to support continuous compliance and product safety. The Director provides global strategic leadership and governance for contamination control, establishes microbiology standards, and drives consistent implementation and harmonization across the manufacturing network. The role provides technical leadership for complex or high-risk microbial investigations, identifies emerging microbiological and regulatory risks, and contributes microbiology expertise to new facilities, technology transfers, capital projects, and product introductions. It also leads technology implementation and Operational Excellence projects and builds a global microbiology community of practice. The position requires a bachelor’s degree and at least 10 years of microbiology experience in a cGMP-regulated biopharmaceutical or pharmaceutical manufacturing environment. A master’s degree with at least 7 years of biopharmaceutical experience is preferred; a doctoral degree with at least 5 years of biopharmaceutical experience is also listed. Travel is up to 20%.

Requirements

Bachelor’s degree.
At least 10 years of microbiology experience in a cGMP-regulated biopharmaceutical or pharmaceutical manufacturing environment.
Deep knowledge of aseptic processing, cleanroom qualification, environmental monitoring, and computerized laboratory systems, including LIMS.
Strong proficiency with Microsoft 365 and relevant laboratory systems, including LIMS.
Strong analytical troubleshooting skills, rigorous attention to detail, and excellent technical writing skills for regulatory submissions and investigation reports.
Ability to travel up to 20%.

Nice To Haves

Master’s degree and at least 7 years of biopharmaceutical experience.
Doctoral degree and at least 5 years of biopharmaceutical experience.

Responsibilities

Provide global strategic leadership and governance for contamination control strategies across manufacturing sites, establishing standards and ensuring consistent implementation and regulatory compliance.
Ensure operations adhere to FDA, EMA, cGMP, and USP/EP compendial standards; act as a subject matter expert during regulatory inspections and audits.
Establish and maintain global microbiology standards and governance for microbial limits testing, sterility testing, endotoxin testing, and bioburden assays covering raw materials, in-process samples, and final drug products.
Drive harmonization of microbiological practices across the global network.
Provide technical leadership for complex or high-risk microbial investigations, including out-of-specification results, environmental monitoring excursions, and contamination events.
Lead root-cause analysis and implement effective Corrective and Preventive Actions (CAPA).
Identify emerging microbiological and regulatory risks and translate them into global Quality standards.
Build and lead a global microbiology community of practice or technical network.
Provide strategic microbiology input to new facilities, technology transfers, major capital projects, and product introductions.
Partner with Manufacturing, R&D, and Engineering to assess microbiological risks using appropriate risk-management methodologies during process changes and facility modifications.
Lead new technology implementation and Operational Excellence (OE) projects.