Associate Director, MQSA Regulatory Intelligence and Standards
Job Location:
New Brunswick, NJ - USA
Yearly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
At Bristol Myers Squibb our employees often ask Who are you working fora 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; escalate 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; escalate 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
Bachelors 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 .
Travel
This position requires up to 10% of travel.
Preferred:
M.S. in Microbiology Pharmaceutical Sciences Biology Biochemistry or a related scientific discipline.
We hire for skills and capabilities not just credentials if this role excites you but doesnt perfectly match your resume we encourage you to apply anyway.
Compensation Overview:
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 carefully considering the nature of the role required skills work location schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors and individual team or Company performance.
Benefits:
Subject to the terms and conditions of the applicable plans then in effect you may be eligible to participate in our comprehensive benefit plans including wellbeing support retirement and financial protection benefits and insurance offerings (medical dental vision life and disability).
U.S.-based exempt employees are eligible for Flexible Time Off (FTO) which provides paid time off without a set accrual limit subject to manager approval along with 11 paid company holidays each year.
Non-exempt employees RayzeBio employees and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval) 11 paid company holidays and 3 optional holidays.
Depending on eligibility employees may also have access to additional time-off benefits including paid sick leave up to two paid volunteer days per year summer hours flexibility and leaves of absence for medical personal parental caregiver bereavement or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Years Day.
U.S.-based job seekers can explore full benefit offerings at We Work
Where you work matters because collaboration innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential site-by-design field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at People with Disabilities
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process reasonable workplaceaccommodations/adjustmentsand ongoing support in their roles. Applicants can request a reasonable workplaceaccommodation/adjustmentprior to accepting a job offer. If you require reasonableaccommodations/adjustmentsin completing this application or in any part of the recruitment process direct your inquiries to. Visit access our complete Equal Employment Opportunity statement.
Candidate Rights
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R: Associate Director MQSA Regulatory Intelligence and Standards
Required Experience:
Director
About Company
Bristol-Myers Squibb is a global biopharmaceutical company focused on discovering, developing and delivering innovative medicines for patients with serious diseases. Our medicines are helping millions of patients around the world in disease areas such as oncology, cardiovascular, immu ... View more
