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

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.