Director, Inspection Readiness

Bristol Myers Squibb • Devens, MA

1d • Hybrid

About The Position

The Director of Inspection Readiness is responsible for ensuring organizational preparedness for regulatory agency inspections (e.g., FDA, EMA, PMDA, etc.) across global pharmaceutical, biologics, cell therapy, and medical device operations. Reporting to the Senior Director of Inspection Readiness, this individual contributor role leverages extensive industry and regulatory experience to drive inspection readiness strategies, conduct gap analyses, and serve as a subject matter expert on regulatory compliance and health authority inspection matters.

Requirements

• Bachelor’s degree in Natural Science, Pharmacy, or related fields, required.
• 10+ years of progressive experience in regulatory compliance and QA/QC, including leadership responsibility, within the pharmaceutical, biologics, cell therapy, and medical device industries.
• Experience planning, leading, and conducting internal audits of pharmaceutical manufacturing sites and laboratories.
• Demonstrated experience supporting Health Authority inspections (e.g., FDA, EMA, MHRA, PMDA), including roles as inspection facilitator/lead, front‑room SME, and back‑room support, with responsibility for inspection readiness, logistics, data management, and cross‑functional regulatory interactions.
• In-depth knowledge of global regulatory requirements (FDA, EMA, PMDA, NMPA, etc.) and GxP standards.
• Exceptional leadership, communication, and influencing skills.
• Proven ability to develop and implement strategic programs and drive organizational change.
• Strong analytical and problem-solving abilities.
• Experience managing large, cross-functional global teams and projects.
• Experience with enterprise-level compliance systems and audit management tools.
• Demonstrated ability to manage multiple complex projects simultaneously.
• Recognized as a thought leader in regulatory inspection readiness within the industry.

Nice To Haves

• Prior experience serving as a Health Authority inspector or regulator, ideally with the FDA or a comparable global Health Authority, is preferred but not required.

Responsibilities

• Support the Senior Director of Inspection Readiness to drive the development, execution, and ongoing evolution of a Global Quality inspection readiness strategy that embeds an “always‑ready” state of compliance.
• Conduct mock inspections, gap analyses, and assessments of inspection readiness for facilities and business units.
• Monitor regulatory intelligence, trends, and changes, integrating Predictive Quality insights to adapt inspection readiness strategies and maintain proactive compliance.
• Consolidate and analyze regulatory observations and lessons learned to inform continuous improvement and prevent repeat observations.
• Ensure inspection‑ready narratives and defensible decision‑making are clearly articulated, demonstrated, and sustained in practice.
• Support the Senior Director as a recognized expert advisor and point of escalation for sites during regulatory inspections, delivering real‑time support and expert review, challenge, and alignment of inspection responses and remediation actions prior to submission to the health authority.
• Collaborate with cross-functional stakeholders to ensure integrated inspection preparedness across all business units.
• Analyze inspection outcomes and drive post-inspection improvement initiatives.
• Work with site principals to ensure effective, local, Inspection Readiness plans are developed and maintained
• Develop robust metrics that best measure the performance of the Inspection Readiness program and that measures the overall inspection preparedness of the BMS Network.
• Champion a culture of compliance, quality, and continuous improvement throughout the organization.
• Serve as a trusted regulatory compliance advisor, guiding regulatory notification strategies, event escalation decisions, and inspection readiness activities to ensure alignment with global health authority expectations.
• Establish and maintain a network of industry contacts to benchmark and adopt best practices in inspection readiness.

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.
• Work-life benefits include: 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
• Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
• All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees