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.

• 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

• 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

• 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
• Driveand 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.

• 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.

• Define contractual and quality agreement requirements for CMO/CDMO aseptic practices, sterility assurance, and…