Associate Director, MQSA Regulatory Intelligence and Standards

Bristol Myers Squibb; Dublin; On-site; EUR 180,000 - 240,000; Full time

Job summary

Bristol Myers Squibb is seeking a senior Regulatory Intelligence & Compliance leader to drive enterprise CCS/SA governance, inspection readiness, and global regulatory strategy across the manufacturing network.

You will translate regulatory intelligence into actionable recommendations, support Health Authority engagements, and partner with site quality teams to ensure compliant operations and sustainable governance.

Qualifications

• Bachelor’s degree in Microbiology, Pharmaceutical Sciences, Biology, Biochemistry or a related field.
• Minimum 14 years of relevant experience in regulatory compliance within biopharma.
• Advanced knowledge of sterility assurance, contamination control, and aseptic processing.

Responsibilities

• Execute enterprise regulatory intelligence and surveillance program; monitor evolving global regulations and health authority expectations.
• Own and maintain governance documentation and standards across CCS/SA.
• Lead day-to-day inspection readiness activities and serve as SME during Health Authority inspections.
• Contribute to the CCS/SA roadmap, performance monitoring, and governance framework adoption.

Education

B.S. in Microbiology, Pharmaceutical Sciences, Biology, Biochemistry

Bachelor’s degree in a related scientific discipline with extensive experience

Job description

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.

Key Responsibilities

Regulatory Intelligence & Compliance Alignment

Executethe 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.

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

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

Supportregulatory 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.

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

Enterprise Governance & Standards

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

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

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

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

Supportthe 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

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

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

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

Strategy, Roadmap & Performance

Contributeto 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.

Defineintegrated 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 maintainCCS/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 Strategyto ensure external partners meet BMS enterprise standards and applicable regulatory expectations, consistent with contractual and quality agreement requirements.

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

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

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

Supportthe 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.

Fostera 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 supportexternal 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 MQSAin 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 (