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  

• 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 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   

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