Associate Director, Inspection Readiness

New Brunswick, NJ - USA

Monthly Salary: Not Disclosed

Posted on: 12 hours ago

Vacancies: 1 Vacancy

Job Summary

Working with Us
Challenging. Meaningful. Life-changing. Those arent 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. Youll 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: Summary
Reporting to the Director Inspection Readiness the Associate Director will help drive the strategy for Inspection Readiness and will on a tactical level execute compliance and inspection support programs in a matrixed organization. This role will also work collaboratively to monitor inspection trends and identify other compliance performance indicators across the network. This role will interact and collaborate extensively with teams and leaders across the BMS 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.

Key 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.

Qualifications & Experience
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.
Bachelors 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.

GPS2025

GQ2025

If you come across a role that intrigues you but doesnt 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:

Devens - MA - US: $175310 - $212438 Madison - Giralda - NJ - US: $163850 - $198543 New Brunswick - NJ - US: $163850 - $198543 Princeton - NJ - US: $163850 - $198543

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 employees 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 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 Years 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.

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 . Visit 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: Protection

We will never request payments financial information or social security numbers during our application or recruitment process. Learn more about protecting yourself at data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Required Experience:

Director

Working with UsChallenging. Meaningful. Life-changing. Those arent 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 breakthrou...

Key Skills

Program assessment
FDA Regulations
Manufacturing & Controls
Program Evaluation
budget forecast
Research Experience
Operations Management
Research & Development
Strategic Planning
Contract Management
Leadership Experience
negotiation

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About Company

Bristol Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company focused on discovering, developing and delivering innovative medicines for patients with serious diseases. Our medicines are helping millions of patients around the world in disease areas such as oncology, cardiovascular, immu ... View more

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