Associate Director, MQSA Regulatory Intelligence and Standards

Key Responsibilities 
Regulatory Intelligence & Compliance Alignment  

Execute the enterprise regulatory intelligence and surveillance program; monitor, analyze, and interpret evolving global regulations, guidance documents, and Health Authority expectations related to aseptic processing, contamination control, and microbial quality (FDA 21 CFR Parts 210/211/600, EU GMP Annex 1 and Part IV, ICH Q9/Q10, USP <797>/<1072>/<71>, PIC/S). Owns updates to global procedures based on the assessments. 

Conduct systematic regulatory change impact assessments and draft change notification packages; escalate significant compliance gaps or emerging regulatory risks for strategic assessment and enterprise response. 

Maintain the regulatory intelligence deliverables library, including gap assessments, applicability matrices, regulatory horizon scanning summaries, and compliance position papers to ensure enterprise-wide readiness. 

Support regulatory engagement strategy with Health Authorities and industry bodies; serve as a primary operational contact during site inspections, agency inquiries, and regulatory filings related to CCS/SA matters. 

Translate regulatory intelligence findings into actionable recommendations, briefing documents, and compliance alignment proposals. 

Enterprise Governance & Standards  

Own and maintain commercial CCS/SA governance documentation, including global procedural documents (GPOs), policies, and standards — ensuring alignment with the overarching enterprise governance framework. 

Execute compliance gap assessments and applicability matrices across aseptic processes, microbial control, and sterility assurance for all relevant manufacturing environments (sterile, aseptic, non-sterile). 

Drive the practical adoption and operationalization of enterprise standards at site level, working closely with site quality teams to ensure scalable and sustainable implementation. 

Establish and maintain governance documents, white papers, storyboards and inspection-ready deliverables supporting the enterprise CCS/SA framework. 

Support the organizational transition from current-state to a single, unified enterprise CCS/SA function with clear decision rights, including workforce transition planning and role definition activities. 

Inspection Readiness & Technical Compliance Support  

Lead day-to-day inspection readiness activities across the commercial manufacturing network related to CCS/SA; serve as the primary operational subject matter expert resource during Health Authority inspections and agency engagements related to CCS/SA. 

Develop and maintain inspection-ready documentation packages, site-level compliance assessments, and regulatory response materials for CCS/SA-related matters. 

Provide technical compliance support related to regulatory interpretation, microbiological data integrity, critical investigations, and inspection readiness activities; escalate complex or high-risk matters to the Senior Director as the enterprise escalation point. 

Coordinate with site quality teams and cross-functional partners to ensure consistent, defensible, science-based responses during regulatory inspections and agency interactions. 

Strategy, Roadmap & Performance  

Contribute to the development of the enterprise CCS/SA roadmap, including input on emerging regulatory requirements, site-level performance gaps, and practical implementation considerations, in support of strategic direction. 

Develop and maintain performance monitoring inputs, tracking site-level compliance performance against enterprise CCS/SA standards. 

Define integrated CCS/SA minimum requirements and decision frameworks applicable across the BMS commercial manufacturing network, consistent with the enterprise strategy. 

CMO/CDMO Standards & Oversight (Operational Accountability) 

Establish and maintain CCS/SA standards in CMO/CDMO quality agreements, defining minimum sterility assurance content requirements and standardizing oversight expectations across the ExM network. 

Coordinate with ExM Compliance and Strategy to ensure external partners meet BMS enterprise standards and applicable regulatory expectations, consistent with contractual and quality agreement requirements. 

Support compliance assessments and audits of external manufacturing partners related to aseptic and microbial control performance. 

Cross-Site Learning, Community of Practice & Capability Development (Network Enablement) 

Drive cross-site learning, community of practice initiatives, and standardized approaches that promote continuous improvement across the Product Development & Supply (PDS)network. 

Support the enterprise aseptic training program by developing and maintaining training content, qualification frameworks, and competency assurance tools, ensuring practical translation into demonstrable improvements in aseptic behaviours and contamination control practices. 

Foster a culture of aseptic discipline, contamination awareness, and quality mindset across manufacturing sites and network partners. 

Coordinate with PD Micro (Micro CoE) to ensure alignment on adoption of new technologies and to provide technical context when central MQSA documents or standards intersect with PD activities. 

External Engagement & Industry Benchmarking (Supporting Enterprise Representation) 

Participate in and support external engagement with regulatory agencies, industry consortia, and professional organizations (e.g., PDA, ISPE, USP expert committees), to monitor the evolving regulatory landscape and benchmark against industry-validated practices. 

Represent MQSA in applicable benchmarking initiatives and emerging science forums, translating external intelligence into meaningful business action and recommendations for leadership. 

 
Qualifications & Experience:  

Education  

Required: B.S. in Microbiology, Pharmaceutical Sciences, Biology, Biochemistry, or a related scientific discipline. 

Experience  

Bachelor's degree or equivalent in a relevant scientific discipline (Microbiology, Pharmacy, Life Sciences, or related field) with a minimum of 14 years of relevant experience. 

Demonstrates advanced knowledge and practical experience of sterility assurance, contamination control strategy, and aseptic processing within a biopharmaceutical commercial manufacturing environment; recognized as an industry expert in CCS/SA regulatory compliance. 

Extensive experience engaging with global Health Authorities (FDA, EMA, PMDA, etc.) in the context of site inspections, agency responses, and regulatory filings related to microbiology and sterility assurance. 

Demonstrated expertise in developing and implementing enterprise-level governance frameworks, global quality standards, policies, and decision frameworks within a regulated biopharma environment. 

Experience in corporate quality roles with accountability across multiple modalities (biologics, cell therapy, external manufacturing) preferred. 

Supervisory experience in leading cross-functional or compliance-focused teams. 

Demonstrated skills in cross-functional partnership, including collaboration with Technical, Quality, and Operations functions at both site and above-site levels. 

Strong understanding of cGMP regulations, relevant pharmacopeial standards (USP, EP, JP), and industry guidance applicable to aseptic processing and sterility assurance. 

Strong organizational, communication, and technical writing skills are required. 

Travel  

• This position requires up to 10% of travel. 

Preferred: 

• M.S. in Microbiology, Pharmaceutical Sciences, Biology, Biochemistry, or a related scientific discipline.