Director, Global Microbiology Governance – Oversight

This is a fully remote position, open to applicants in United States.

📋 Description

• Deliver global strategic leadership and governance for contamination control strategies across manufacturing locations.

• Set standards and ensure their consistent application and regulatory adherence.

• Guarantee operations comply with FDA, EMA, cGMP, and USP/EP compendial standards.

• Serve as a subject matter expert during regulatory inspections and audits.

• Develop and uphold global microbiology standards and governance for microbial limits, sterility, endotoxin, and bioburden testing.

• Propel the harmonization of microbiological practices across the global network.

• Offer technical leadership for complex or high-risk microbial investigations, including Out of Specification (OOS) results, Environmental Monitoring excursions, and contamination incidents.

• Lead root-cause analysis and enact effective Corrective and Preventive Actions (CAPA).

• Recognize emerging microbiological and regulatory risks and convert them into global quality standards.

• Build and manage a global microbiology community of practice or technical network.

• Provide strategic microbiology insights for new facilities, technology transfers, capital projects, and product launches.

• Collaborate with Manufacturing, R&D, and Engineering to evaluate microbiological risks during process modifications and facility changes.

• Spearhead new technology implementations and Operational Excellence initiatives.

• Exhibit leadership through global influence, governance, and expertise.

⛳️ Requirements

• A Bachelor’s degree along with 10+ years of microbiology experience in a cGMP-regulated biopharmaceutical or pharmaceutical manufacturing setting is required.

• A Master’s degree with 7+ years of experience in Biopharmaceuticals is preferred.

• A Doctoral degree with 5+ years of experience in Biopharmaceuticals is also considered.

• Strong proficiency in Microsoft 365 and relevant laboratory systems, including Laboratory Information Management Systems (LIMS).

• Extensive knowledge of aseptic processing, cleanroom qualification, environmental monitoring, and computerized laboratory systems (LIMS).

• Excellent analytical troubleshooting abilities.

• Exceptional attention to detail.

• Strong technical writing skills for regulatory submissions and investigation reports.

• Familiarity with FDA, EMA, cGMP, and USP/EP compendial standards.

• Willingness to travel up to 20%.

🏝️ Benefits

• Eligibility for an annual bonus plan for non-commercial roles.

• Eligibility for an incentive compensation plan for commercial roles.

• Access to discretionary equity awards.

• Participation in the Employee Stock Purchase Plan.

• Comprehensive medical coverage.

• Dental benefits.

• Vision insurance.

• 401(k) retirement plan.

• Flexible Spending Account (FSA) and Health Savings Account (HSA) options.

• Life insurance coverage.

• Paid Time Off (PTO).

• Wellness programs.