Sr. Director, Compliance & Strategy, MQSA

Bristol Myers Squibb•Devens, MA

8d•$210,190 - $272,528•Hybrid

About The Position

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.

Requirements

Bachelor's degree in Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related scientific discipline
15+ years of progressive pharmaceutical industry experience in microbiology, sterility assurance, contamination control, or aseptic processing
Minimum 8–10 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 <797>/<1072>/<71>, 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
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

Nice To Haves

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

Responsibilities

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
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.
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 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.
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.
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.

Benefits

wellbeing support
retirement and financial protection benefits
insurance offerings (medical, dental, vision, life and disability)
Flexible Time Off (FTO)
11 paid company holidays
160 hours of paid vacation annually
3 optional holidays
paid sick leave
up to two paid volunteer days per year
summer hours flexibility
leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs
annual Global Shutdown between Christmas Day and New Year's Day