Sr. Director, Compliance & Strategy, MQSA

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

• Providesite 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

• Governcompliance gap assessments and applicability matricesfor 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 theenterprise aseptic and microbial control roadmap, including long-range strategic objectives, KPIs, and performance monitoring frameworks

• Own the enterprisecontamination control strategy, CCS frameworks, and harmonization roadmapintegrating 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

• Providecentralized aseptic and microbial control technical oversightacross the full manufacturing network, including internal sites and contract partners

Regulatory Intelligence & Compliance Alignment

• Define, maintain, and govern enterpriseaseptic 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 assessmentsto ensure timely enterprise readiness for evolving regulatory requirements related to aseptic processing

• Leadenterprise aseptic and microbial control regulatory engagement strategyin both sterile and non-sterile manufacturing contexts, including engagement with health authorities and industry bodies.

• Provideregulatory interpretation supportfor internal audits and regulatory inspections, ensuring consistent, defensible, science-based responses.

Inspection Readiness & Technical Compliance Support

• Supportregulatory inspection readinessat internal manufacturing facilities and contract manufacturers, serving as a subject matter expert resource during health authority inspections.

• Providegeneral and microbiological technical compliance supportrelated 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

• Definecontractual and quality agreement requirementsfor 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 foraseptic training, capability development, and competency assurance, including aseptic technique qualification, gowning qualification, and annual requalification programs.

• Maintain and continuously improve theglobal 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

• Leadexternal engagementwith 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+ yearsof progressive pharmaceutical industry experience in microbiology, sterility assurance, contamination control, or aseptic processing

• Minimum8 310 yearsin senior leadership roles with enterprise-level accountability for manufacturing, technology, quality, compliance, or regulatory strategy

• Deep experience across multiple manufacturing modalities, includingsmall molecule, biologics, cell therapy, or gene therapy

• Demonstrated expertise inglobal 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 supportingregulatory inspections(FDA PAI/GMP, EMA, MHRA, or equivalent)

• Experience governingCMO/CDMO quality relationshipsand aseptic compliance requirements

• Track record of successfully leading enterprise-wideharmonization and change management programs

Competencies & Skills

• Exceptionalscientific and technical depthin aseptic processing, contamination control, microbial quality, and sterility assurance

• Strongstrategic thinkingand ability to translate complex scientific and regulatory requirements into actionable enterprise frameworks

• Proven ability toinfluence without direct authorityacross a global, matrixed organization

• Executive-levelcommunication and presentationskills; ability to engage credibly with health authorities, senior leadership, and external partners

• Strongrisk assessment and decision-makingcapabilities 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

#LI- Hybrid

We hire for skills and capabilities, not just credentials 6 if this role excites you, but doesn 2t perfectly match your resume, we encourage you to apply anyway.

Compensation Overview:

Devens - MA - US: $224,900 - $272,528
Madison - Giralda - NJ - US: $210,190 - $254,698
New Brunswick - NJ - US: $210,190 - $254,698
Princeton - NJ - US: $210,190 - $254,698

The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully 6 carefully considering the nature of the role, required sk