Bristol Myers Squibb · 6 hours ago
Associate Director, Inspection Readiness
Princeton, NJ
Full-time
Hybrid
Senior Level, Lead/Staff, Director/Executive
$175K/yr - $212K/yr
7+ years expBristol Myers Squibb is a company that transforms the lives of patients through innovative work. The Associate Director of Inspection Readiness will drive strategy and execute compliance programs, monitoring inspection trends and collaborating with teams across the organization to ensure inspection readiness.
BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
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
Qualification
Required
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
Health Coverage: Medical, pharmacy, dental, and vision care.
Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Paid Time Off
US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
Up to 2 paid volunteer days per year
Leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs
An annual Global Shutdown between Christmas and New Years Day.
Company
Bristol Myers Squibb
At Bristol Myers Squibb, we work every day to transform patients’ lives through science.
10001+ employees
H1B Sponsorship
Bristol Myers Squibb has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (213)
2024 (278)
2023 (231)
2022 (180)
2021 (181)
2020 (169)
Funding
Current Stage
Public CompanyTotal Funding
$29.32BKey Investors
Venrock
2025-11-05Post Ipo Debt· $5.74B
2024-02-14Post Ipo Debt· $13B
2023-10-30Post Ipo Debt· $4.5B
Leadership Team
Charles Bancroft
CFO
Cristian Massacesi
Executive Vice President, Chief Medical Officer and Head of Development
Recent News
2025-12-30
BioWorld Financial Watch
2025-12-29
2025-12-25
Company data provided by crunchbase