Director, Inspection Readiness

Director Of Inspection Readiness

Working with Us 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.

The Director of Inspection Readiness is responsible for ensuring organizational preparedness for regulatory agency inspections (e.g., FDA, EMA, PMDA, etc.) across global pharmaceutical, biotech, cell therapy, and medical device operations. Reporting to the Senior Director of Inspection Readiness, this individual contributor role leverages extensive regulatory experience, including prior service as a Consumer Safety Officer (CSO) or similar role with the US Food & Drug Administration (FDA), to drive inspection readiness strategies, conduct gap analyses, and serve as a subject matter expert on compliance and regulatory inspection matters.

Duties And Responsibilities

Support the Senior Director of Inspection Readiness to develop, implement, and continuously enhance the Global Quality inspection readiness strategy and framework.

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.

Support the Senior Director as an expert advisor and point of contact for site guidance during regulatory inspections, providing real-time support, high-level oversight of inspection conduct, response management, remediation activities, and direct communication with regulatory agencies.

Collaborate with cross-functional stakeholders to ensure integrated inspection preparedness across all business units.

Analyze inspection outcomes and drive post-inspection improvement initiatives.

Works 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 measure the overall inspection preparedness of the BMS Network.

Champion a culture of compliance, quality, and continuous improvement throughout the organization.

Responsible for the management and execution of the GROe process.

Advise on compliance matters by providing guidance on regulatory notifications, escalation of events, and readiness for regulatory inspections.

Establish and maintain a network of industry contacts to benchmark and adopt best practices in inspection readiness.

Qualifications And Requirements

Bachelor's degree in Natural Science, Pharmacy, or related fields, required.

10+ years of relevant experience in regulatory affairs, compliance, or quality assurance in the pharmaceutical, biotech, cell therapy, and medical device industries.

Minimum of 5 years' experience as a Consumer Safety Officer (CSO) or in a similar role at the US Food & Drug Administration (FDA), with FDA employment within the past 10 years (2015-2025) required.

Extensive experience conducting inspections in pharmaceutical (medical device, biologics) facilities.

In-depth knowledge of global regulatory requirements (FDA, EMA, PMDA, 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.

This position requires 30-50% travel.

Compensation Overview : Devens - MA - US : $200,840 - $243,368 Madison - Giralda - NJ - US : $187,700 - $227,445 New Brunswick - NJ - US : $187,700 - $227,445 Princeton - NJ - US : $187,700 - $227,445

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 careers.bms.com / life-at-bms / .

Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following : 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.

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.

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.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

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 / .

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