[Hiring] Director, Global Microbiology Governance & Oversight @BeiGene

Role Description

The Director, Global Microbiology Governance & Oversight ensures the safety, purity, and efficacy of biopharmaceutical products. This role oversees contamination control strategies, environmental monitoring programs, and microbial identification systems across manufacturing facilities. The Director will align laboratory operations with global regulatory standards to ensure continuous compliance and product safety.

• Provide global strategic leadership and governance for contamination control strategy across manufacturing sites, establishing standards and ensuring consistent implementation and regulatory compliance.
• Ensure all operations strictly 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 related to microbial limits testing, sterility testing, endotoxin testing, and bioburden assays for raw materials, in-process samples, and final drug products across manufacturing sites.
• Drive harmonization of microbiological practices across the global network.
• Provide technical leadership for complex or high-risk microbial investigations across sites, such as out-of-Specification (OOS) 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/or 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 Operation Excellence (OE) projects.

Qualifications

• Bachelor’s degree and 10+ years of microbiology experience in a cGMP-regulated biopharmaceutical or pharmaceutical manufacturing environment required.
• Master’s degree and 7+ years of Biopharmaceutical experience preferred.
• Doctoral Degree and 5+ years of Biopharmaceutical experience.

Requirements

• Strong proficiency with Microsoft 365 and relevant laboratory systems, including LIMS.
• Deep knowledge of aseptic processing, cleanroom qualification, environmental monitoring, and computerized laboratory systems (LIMS).
• Strong analytical troubleshooting skills, rigorous attention to detail, and excellent technical writing skills for regulatory submissions and investigation reports.
• Travel: Up to 20%.

Benefits

• Salary Range: $168,000.00 - $228,000.00 annually.
• Comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
• All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan.

Company Description

BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. The recruiter can share more about the specific salary range for a preferred location during the hiring process.

We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.

In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact [email protected].