Associate Director, Inspection Readiness

Bristol-Myers Squibb • Princeton, NJ

118d • $163,850 - $212,438 • Hybrid

About The Position

The Associate Director will help drive the strategy for Inspection Readiness and will execute compliance and inspection support programs in a matrixed organization. This role will also work collaboratively to monitor inspection trends and identify compliance performance indicators across the network. The Associate Director will support BMS' GMP/GDP Inspection Readiness strategy by supporting on-site and remote assessments of BMS internal and external sites, providing real-time support based on a risk-based approach.

Requirements

• A minimum of seven (7) years' experience in the Biopharm/Pharmaceutical industry.
• Bachelor's degree in Natural Science, Pharmacy, or related fields.
• Experience conducting inspections in pharmaceutical facilities and working for the US FDA as a Consumer Safety Officer (CSO) within the past 10 years.
• Demonstrated negotiation, risk management, relationship management and conflict resolution skills.
• Proven ability to understand complex processes/problems and propose alternate solutions.
• Ability to work in a matrixed organization and influence areas not under direct control.
• Proficiency in gathering insights from data analytics and advanced analytics tools.

Nice To Haves

• Demonstrated innovation, flexibility, open-mindedness, and adaptability.
• Ability to complete multiple, simultaneous projects with minimal supervision.
• In-depth knowledge of Global Health Authority regulations and quality systems principles.

Responsibilities

• Monitor and assess global regulatory inspection outcomes, enforcement actions, quality and compliance metrics, and external signals.
• Cultivate and sustain strategic partnerships with External Engagement, Quality Risk Management and Operations & Performance.
• Conduct independent enterprise reviews of regulatory interactions to assess communications and commitments with health authorities.
• Serve as a subject matter expert to review and advise on regulatory notification strategies.
• Develop and maintain strong partnerships with cross-functional teams and stakeholders across the product lifecycle.
• Perform comprehensive on-site or remote inspection readiness assessments at BMS sites and with external partners.
• Ensure the appropriate preparation, execution, and follow-up of inspection readiness activities.
• Partner with site Quality and Compliance teams to prepare for and manage global regulatory inspections.
• Ensure the effective management of the GROe program to analyze audit and inspection findings.
• Lead or participate in sharing best practices and lessons learned.

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).
• Paid national holidays and optional holidays.
• Up to 120 hours of paid vacation.
• Up to two (2) paid days to volunteer.
• Parental, caregiver, bereavement, and military leave.
• Tuition reimbursement and a recognition program.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree