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.

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