Sr. Director, Compliance & Strategy, MQSA
Job Location:
Devens, MA - 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
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 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
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
Bachelors 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
Minimum810 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 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
BMS will consider qualified applicants with arrest and conviction records pursuant to applicable laws in your area.
For roles based in Los Angeles County only: If you live in or expect to work from Los Angeles County if hired for this position please visit this page for important additional information: Protection
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R: Sr. Director Compliance & Strategy MQSA
Required Experience:
Exec
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
