Director, Global Microbiology Governance & Oversight

BeiGene Ltd.; United States; Remote; USD 168,000 - 228,000; Full time

Job summary

BeOne Medicines Ltd. in the United States seeks a seasoned Director, Global Microbiology Governance & Oversight to lead contamination control strategies and global environmental monitoring across manufacturing sites.

You will align operations with FDA/EMA/cGMP/USP standards, drive harmonization of microbiology practices, and guide high‑risk investigations, CAPA, and technology transfers to ensure product safety and regulatory compliance.

Qualifications

• Bachelor's degree in microbiology or related field with 10+ years in cGMP-regulated biopharmaceuticals.
• Master's degree preferred with 7+ years in biopharma.
• Doctoral degree with 5+ years preferred.

Responsibilities

• Provide global strategic leadership and governance for contamination control across manufacturing sites.
• Ensure FDA/EMA/cGMP/USP standards; act as SME during regulatory inspections and audits.
• Establish and maintain global microbiology standards for microbial limits, sterility, endotoxin testing, and bioburden.
• Drive harmonization of microbiological practices across the global network.
• Provide technical leadership for high-risk microbial investigations and CAPA.
• Identify emerging microbiological and regulatory risks and translate into standards.
• Build and lead a global microbiology community of practice.
• Provide strategic microbiology input to new facilities, tech transfers, and major projects.
• Collaborate with Manufacturing, R&D, and Engineering to assess risks during changes.
• Lead new technology implementation and Operation Excellence projects.

Skills

Leadership

Analytical thinking

Regulatory compliance

Technical writing

Problem solving

Education

Bachelor's degree

Master's degree

Doctoral Degree

Tools

LIMS

Microsoft 365

GxP systems

Job description

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

Director, Global Microbiology Governance & Oversight

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.

Essential Functions of the Job

• 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.

Supervisory Responsibilities

Leadership through global influence, governance, expertise.

Computer Skills

Strong proficiency with Microsoft 365 and relevant laboratory systems, including LIMS.

Other Qualifications

Technical Expertise: Deep knowledge of aseptic processing, cleanroom qualification, environmental monitoring, and computerized laboratory systems (LIMS).

Core Competencies: Strong analytical troubleshooting skills, rigorous attention to detail, and excellent technical writing skills for regulatory submissions and investigation reports.

Travel

Up to 20%

Education

• 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

Global Competencies

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

Salary Range: $168,000.00 - $228,000.00 annually

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. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. 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. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

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 [e-mail] .