Director, Inspection Readiness
Bristol Myers Squibb
This listing was originally posted on Bristol Myers Squibb's careers page. Formulate is an equal opportunity job aggregator and is not involved in the hiring process. Where salary information is estimated, it is derived from BLS industry benchmarks and may differ from actual compensation.
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Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.
Position Summary:
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.
Duties and 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.
Qualifications and skills required:
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.
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.
Travel:
This position requires 30-50% travel.
#LI-Hybrid
If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Compensation Overview:
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.
Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:
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.
*Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
Supporting People with Disabilities
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Candidate Rights
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
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: https://careers.bms.com/california-residents/
Data Protection
We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.
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