Sr. Director, Compliance & Strategy, MQSA

Sr. Director, Compliance & Strategy, MQSA

At Bristol Myers Squibb, our employees often ask, "Who are you working for?"a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Key Responsibilities

Enterprise Governance & Frameworks

• Own and maintain the enterprise CCS/SA governance framework, including standards, policies, procedures, and Global Procedural Oversight documents (GPOs) spanning sterile, aseptic, and microbial control practices across all modalities and manufacturing environments
• Provide site Environmental and Aseptic Control (EAC) governance and oversight, ensuring alignment with enterprise standards and regulatory expectations
• Define, maintain, and continuously improve the enterprise contamination control requirements and risk methodologies applicable to all product types and manufacturing settings
• Govern compliance gap assessments and applicability matrices for aseptic processes, microbial control, and SA requirements across the internal and external manufacturing network
• Drive adoption of enterprise standards into site-level operations, ensuring practical, scalable and sustainable implementation

Strategy, Roadmap & Performance

• Define the enterprise aseptic and microbial control roadmap, including long-range strategic objectives, KPIs, and performance monitoring frameworks
• Own the enterprise contamination control strategy, CCS frameworks, and harmonization roadmap integrating sterile, aseptic, and non-sterile manufacturing programs into a cohesive, risk-based enterprise approach
• Identify and evaluate emerging aseptic processing and microbial control technologies, driving industry benchmarking and innovation adoption into enterprise strategy
• Provide centralized aseptic and microbial control technical oversight across the full manufacturing network, including internal sites and contract partners

Regulatory Intelligence & Compliance Alignment

• Define, maintain, and govern enterprise aseptic and microbial regulatory intelligence and surveillance programs, including systematic interpretation of evolving global regulations, guidance, and expectations related to aseptic processing, contamination control, and microbial quality
• Drive and own change notification, compliance alignment, and regulatory change impact assessments to ensure timely enterprise readiness for evolving regulatory requirements related to aseptic processing
• Lead enterprise aseptic and microbial control regulatory engagement strategy in both sterile and non-sterile manufacturing contexts, including engagement with health authorities and industry bodies
• Provide regulatory interpretation support for internal audits and regulatory inspections, ensuring consistent, defensible, science-based responses

Inspection Readiness & Technical Compliance Support

• Support regulatory inspection readiness at internal manufacturing facilities and contract manufacturers, serving as a subject matter expert resource during health authority inspections
• Provide general and microbiological technical compliance support related to regulatory interpretation, microbiological data integrity, critical investigations, and inspection readiness activities
• Serve as an enterprise escalation point for complex or high-risk microbial and sterility assurance compliance matters

CMO/CDMO Governance

• Define contractual and quality agreement requirements for CMO/CDMO aseptic practices, sterility assurance, and microbial control obligations, ensuring external partners meet BMS enterprise standards and applicable regulatory expectations
• Oversee compliance assessments and audits of external manufacturing partners related to aseptic and microbial control performance

Training, Capability & Competency Development

• Define and govern enterprise requirements for aseptic training, capability development, and competency assurance, including aseptic technique qualification, gowning qualification, and annual requalification programs
• Maintain and continuously improve the global aseptic training program, content library, and qualification frameworks across all manufacturing sites and personnel categories
• Foster a culture of aseptic discipline, contamination awareness, and quality mindset across the manufacturing network
• Ensure training programs translate into demonstrable improvements in aseptic behaviors, contamination control practices, and inspection readiness

External Engagement & Industry Leadership

• Lead external engagement with regulatory agencies, industry consortia, and professional organizations (e.g., PDA, ISPE, USP expert committees) to shape industry standards and best practices
• Represent BMS in benchmarking initiatives and emerging science forums related to aseptic processing and microbial control

Qualifications & Experience Education

• Bachelor's degree in Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related scientific discipline

Experience

• 15+ years of progressive pharmaceutical industry experience in microbiology, sterility assurance, contamination control, or aseptic processing
• Minimum 810 years in senior leadership roles with enterprise-level accountability for manufacturing, technology, quality, compliance, or regulatory strategy
• Deep experience across multiple manufacturing modalities, including small molecule, biologics, cell therapy, or gene therapy
• Demonstrated expertise in global regulatory frameworks (FDA 21 CFR Parts 210/211/600, EU GMP Annex 1 and Part IV, ICH Q9/Q10, USP //, PIC/S, and other applicable guidance)
• Proven experience leading or supporting regulatory inspections (FDA PAI/GMP, EMA, MHRA, or equivalent)
• Experience governing CMO/CDMO quality relationships and aseptic compliance requirements
• Track record of successfully leading enterprise-wide harmonization and change management programs

Competencies & Skills

• Exceptional scientific and technical depth in aseptic processing, contamination control, microbial quality, and sterility assurance
• Strong strategic thinking and ability to translate complex scientific and regulatory requirements into actionable enterprise frameworks
• Proven ability to influence without direct authority across a global, matrixed organization
• Executive-level communication and presentation skills; ability to engage credibly with health authorities, senior leadership, and external partners
• Strong risk assessment and decision-making capabilities in ambiguous and high-stakes environments
• Demonstrated ability to build, lead, and develop high-performing, globally dispersed teams

Preferred:

• Advanced degree (M.S. or Ph.D.) in Microbiology or a related field