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About the role
- Associate Director managing inspection readiness strategies at Bristol Myers Squibb. Driving compliance and inspection support programs in a matrixed organization across the biopharmaceutical sector.
Responsibilities
- Monitor and assess global regulatory inspection outcomes, enforcement actions, quality and compliance metrics, and external signals, leveraging these insights to anticipate regulatory expectations, shape enterprise-wide inspection readiness strategies, and drive proactive, continuous improvement.
- Cultivate and sustain strategic partnerships with External Engagement, Quality Risk Management and Operations & Performance to identify, prioritize, and drive the implementation of initiatives that advance benchmark performance in automated predictive risk. Provide oversight to ensure alignment with organizational objectives and the integration of innovative solutions across the enterprise.
- Conduct independent enterprise reviews of regulatory interactions to objectively assess communications and commitments with health authorities, ensuring consistency, identifying gaps or risks, and enabling proactive remediation.
- Serve as a subject matter expert to review and advise on regulatory notification strategies by providing expert guidance on the interpretation and application of global regulatory requirements, as required.
- Develop and maintain strong partnerships with cross-functional teams and stakeholders across the end-to-end product lifecycle, from development through commercialization, to identify, share, and implement best practices and innovative solutions that advance benchmark inspection readiness and support a culture of quality and compliance.
- Perform comprehensive on-site or remote inspection readiness assessments at BMS sites and with external partners, utilizing standardized tools and methodologies to evaluate preparedness, reduce regulatory inspection risk, and provide expert inspection support and guidance as needed.
- Ensure the appropriate preparation, execution, and follow-up of inspection readiness activities so that sites and functions are fully inspection-ready. This includes overseeing pre-inspection audits, mock interviews, training sessions, storyboard reviews, logistics coordination, and the timely escalation of critical issues.
- Partner with site Quality and Compliance teams to prepare for and manage global regulatory inspections, including supporting the creation of comprehensive written responses to inspection observations and reports.
- Ensure the effective management of the GROe program to analyze audit and inspection findings, proactively reducing inspection risk, and coordinate across the enterprise to achieve end-to-end inspection readiness. Continuously identify opportunities to enhance and improve the GROe process.
- Lead or participate in sharing best practices and lessons learned, collaborate to standardize and improve processes, and motivate teams for strong inspection performance.
Requirements
- A minimum of seven (7) years’ experience in the Biopharm/Pharmaceutical industry with in-depth knowledge and experience in global auditing procedures and best practices.
- Bachelor’s degree in Natural Science, Pharmacy, or related fields, required.
- The candidate will have previously conducted inspections in pharmaceutical (medical device, biologics) facilities and have worked for the US Food & Drug Administration (FDA), within the past 10 years (2015-2025) in a Consumer Safety Officer (CSO) or similar role; minimum of 5 years’ experience as a CSO required.
- Demonstrated negotiation, risk management, relationship management and conflict resolution skills.
- Proven ability to understand complex processes/problems and propose alternate solutions.
- Demonstrates innovation, flexibility, open-mindedness, and adaptability to meet objectives in a rapidly changing environment with shifting priorities.
- Demonstrated ability to work in a matrixed organization with a range of technically, culturally, and geographically diverse teams and to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives.
- Able to complete multiple, simultaneous projects with minimal supervision and prioritize incoming work appropriately.
- Has a proven track record of working across the network to find common solutions and drive positive impact and benefits for patients.
- In-depth knowledge of Global Health Authority regulations, quality systems principles and applications to the pharmaceutical industry.
- Ability to communicate and collaborate with employees and management at all levels and through various formats (e.g. presentations, written proposals, reports, correspondence, lead meetings, face-to-face dialogue, etc.).
- Proficiency in gathering insights from data analytics and advanced analytics tools.
- Travel: up to 25% , may exceed this travel requirement, if needed by the business.
Benefits
- Medical, pharmacy, dental and vision care.
- Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).
- Financial well-being resources and a 401(K).
- Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support.
- Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility.
- Parental, caregiver, bereavement, and military leave.
- Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources.
- Other perks like tuition reimbursement and a recognition program.
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