Senior Director, Enterprise Aseptic & Microbial Compliance

Bristol Myers Squibb; United States; Hybrid; USD 210,000 - 280,000; Full time

Benefits offered by this job

Flexible Time Off

11 paid company holidays

Comprehensive health benefits

Job summary

Bristol Myers Squibb is seeking a senior leader to shape enterprise aseptic and microbial control strategies, governance, and regulatory alignment across all manufacturing modalities. You will lead cross-functional teams, engage with health authorities, and drive harmonization and continuous improvement across the network.

The role requires extensive experience in sterile processing, quality, and regulatory strategy, with a track record of influencing global partners and leading change programs.

Qualifications

• Bachelor's degree in Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related scientific discipline.
• 15+ years pharma industry experience in microbiology, sterility, contamination control, or aseptic processing.
• 8–10+ years in senior leadership with enterprise-level accountability.
• Experience across multiple manufacturing modalities (small molecule, biologics, cell/gene therapy).
• Deep experience with global regulatory frameworks (FDA, EU GMP, ICH, USP).
• Proven track record in regulatory inspections and CMO/CDMO governance.
• Track record of enterprise-wide harmonization and change management.

Responsibilities

• Own and maintain the enterprise CCS/SA governance framework across modalities and environments.
• Define and improve the enterprise contamination control requirements and risk methodologies.
• Drive adoption of enterprise standards into site operations and partner networks.
• Define the enterprise aseptic/microbial control roadmap and KPIs.
• Provide centralized technical oversight across the manufacturing network.
• Lead regulatory engagement strategies for sterile and non-sterile contexts.
• Support inspections with science-based responses and compliance perspectives.
• Oversee contractual and quality requirements for CMO/CDMO partners.
• Develop enterprise training programs for aseptic technique and qualification.

Skills

Governance strategy

Regulatory strategy

Executive communication

Matrix leadership

Risk assessment

Industry benchmarking

Quality and compliance

Education

Bachelor's degree in Microbiology/biochemistry/pharmaceutical sciences or related field

Job description

Bristol Myers Squibb is seeking a senior leader to shape enterprise aseptic and microbial control strategies, governance, and regulatory alignment across all manufacturing modalities. You will lead cross-functional teams, engage with health authorities, and drive harmonization and continuous improvement across the network.

The role requires extensive experience in sterile processing, quality, and regulatory strategy, with a track record of influencing global partners and leading change programs.