**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 rich in diversity. 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 Associate Director, Inspection Lead will work in the RDQ, CQA- Clinical Inspection Management group. This group conducts inspection risk assessments, prepares for, and coordinates, all types of GCP inspections (including routine, directed or submission related inspections), and leads business critical GCP inspections. This group collaborates with other GxP quality functions, as appropriate. This role reports to the Head of Clinical Inspection Management. **Key Responsibilities:** + Inspection readiness and preparation + Acts as CIM Inspection Lead for high-risk submissions, contributing to inspection preparation strategy and activities. + Conducts assessments that determine risk of potential and/or upcoming inspection to guide resourcing and preparation efforts. + Ensures required business stakeholders and GQ are notified of anticipated and announced GCP inspections. + Collaborates with the Inspection Coordinator to create and maintain an inspection toolbox to facilitate the coordination of worldwide health authority GCP inspections. + Ensures strategic inspection preparation with all stakeholders focused on areas of highest impact through the conduct of mock inspections, preparation of story boards, and document review. + Influences, anticipates, and acts on trends and changes in the international regulatory environment and new developments internally and externally in the GCP area to adapt inspection readiness and preparation, as needed. + Conducts pre-inspection visits and/or sponsor assessments, as needed. + Leads HA inspection dossier preparation and document compilation/QC, as needed. + Collaborates with Global Process Owners (GPOs) to ensure process level inspection preparation. + Ensures all GCP inspections are tracked and entered into QMS. + Inspection management and follow-up + Leads key regulatory agency inspections of high risk and impact to the company, including anticipating issues that may pose risk, and provides strategic input into SME(s) to be engaged and BMS position on inspection responses. + Reviews and approves all documents and responses shared with inspectors to mitigate potential risks and ensures appropriate stakeholders are involved. + Facilitates collection of responses to inspection findings, critically evaluates proposed CAPAs, and maintains oversight of health authority commitments. + Influences the way inspections are conducted by the health authorities through being a constructive partner in improving future ways of working. + Monitors the GCP landscape for new trends in inspection focus in partnership with PEARL, GROe and stakeholders. + Identifies trends and ensures lessons learned from inspections to proactively prevent risks in future submissions. + Reviews results/analyses of GCP inspections, including inspections of clinical investigator sites, vendors, and sponsor systems to assess regulatory compliance and, where appropriate, addresses issues with BMS management to assure proper follow-up and resolution. **Qualifications & Experience:** + Minimum of BA/BS degree (University Graduate) in relevant discipline (life sciences degree preferred) + Demonstrated expertise and specific technical knowledge of the GCP areas subject to inspection and audit, as evidenced by at least 8 years in the pharmaceutical industry or equivalent. + Minimum 6 years technical auditing/inspection management and/or related experience; GCP auditing/inspections preferred + Comprehensive demonstrated working knowledge of principles and concepts of QA, including those related to Quality Risk Management (QRM), critical thinking and QbD (Quality by Design); consistently identifies and escalates areas of highest risk + Comprehensive knowledge of ICH-GCP Guidelines and other international GxP regulations, as appropriate + Detailed and comprehensive understanding of the drug development process and risk analysis + Comprehensive GCP inspection management skills that demonstrate ability to lead and organize study teams in preparation activities, critically review documentation for risks, coach SMEs in inspection best practices, manage efficient front and backrooms during inspections, and lead effective inspection responses. + Broad working knowledge of other disciplines in stakeholder organizations, effectively influencing and supporting improvements in products, processes, and services. + Skilled negotiator, able to effectively influence and obtain cooperation from colleagues, business partners and other stakeholders, including senior management + Excellent critical thinking skills, excellent prioritization, and sound judgement + Demonstrated strength in anticipating, evaluating, and solving multiple problems with varying degrees of complexity for RDQ and stakeholder functions. + Excellent presentation skills, ability to deliver focused messages to audience of peers, stakeholders, and health authority inspectors. + Maintains the confidentiality and security of information, data, documents, and records. + Demonstrates flexibility, open-mindedness, and adaptability to a rapidly changing environment. + Ability to make ethical, scientifically sound recommendations, consistent with company policy/strategy and cost effective \#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. **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 an inclusive culture, promoting diversity 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 a diverse 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/ (https://careers.bms.com/eeo-accessibility) 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/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. **Company:** Bristol-Myers Squibb **Req Number:** R1588931 **Updated:** 2025-02-03 02:13:36.218 UTC **Location:** Remote Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.