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.

Key Responsibilities
• Prepare, manage, host, and follow up of Health Authority Sponsor / MAH inspections, with focus on the global PV system, interactions across GxP and the supporting QMS
• Conduct inspection risk assessments, prepare for and coordinates all types of GCP inspections (including routine, directed or submission related inspections) and lead business critical GCP inspections (in collaboration with other GxP audi and compliance functions and RDQ Quality Operations, as appropriate)
• Review Corrective and Preventative Action Plans (CAPA) to address findings from Health Authority inspections
• Develop, deliver and support inspection readiness training sessions
• Followup on learnings from inspection preparation and management experience, with focus on strategic and highly complex issues
• Oversee changes in global pharmaceutical legislation and the impact on the BMS global PV system, GCP and QMS through, e.g. PEARL
• Serve as a subject matter expert on Clinical Development & PV related topics
• Establish strong partnership with business stakeholders.
• Participate in the preparation, hosting and folloup of regulatory authority inspections related to clinical development, clinical safety and pharmacovigilance activities at central sites, affiliates and partners/vendors, as assigned
• Ensures strategic inspection preparation with all stakeholders focused on areas of highest impact through e.g. the conduct of mock inspection and preparation of story boards
• Conducts preinspection visits and/or sponsor assessments, as needed.
• Maintain an indepth knowledge of regulations as they apply throughout a product’s life cycle, with primary focus on clinical development, clinical safety/PV, and act as an expert resource/trainer
• Participate in GPS and/or BMS company process‐ and improvement initiatives, as assigned; • Lead or co‐lead compliance Investigations, as assigned.
• Supervise inspection management staff, including responsibility for providing ongoing guidance, development and performance assessment and/or manage a local audit function as assigned
• Represent the RDQ‐ CT/ PV & Lifecycle Management Quality position during internal and external meetings, as require
• Partner with quality leads involved in Clinical Development, RA and MA activities, throughout the product lifecycle. Assess specific risk areas ‐ brings ideas and strategies to the forefront and propose modifications to the QMS where necessary. Identify and drive continuous quality process improvements. Integrate end –to end quality principles.
• Establish strong partnership with business stakeholder: seek to understand and evaluate their priorities, actively participate in and make meaningful contributions, deliver independent expert support and propose solutions, present key data (compliance, conformance, issues and risks) to drive decision making.
• Act as an expert and advise on clinical development, clinical safety/ pharmacovigilance related matters and provide guidance and training on relevant GxP regulations and guidelines to cross‐ functional business partners.

Qualifications & Experience
• University Graduate in Pharmacy, Medicine or Life Sciences.
• Extensive experience in Clinical Development, Pharmacovigilance and Regulatory Affairs, including the management of Health Authority inspections. GCP and GVP QA Auditing experience preferred or equivalent in combination ofeducation, training and operational experience in Pharmacovigilance and GCP areas.
• Demonstrated expertise and specific technical knowledge of clinical development, clinical safety and pharmacovigilance, regulatory affairs and/or medical affairs requirements/activities. A minimum of at least 8 years in pharmaceutical industry within a GCP/GVP Quality role, with a minimum of 6 years technical GCP/GVP auditing and/or local Health Authority (China) inspection management experience.
• Sound knowledge of the global QMS requirements throughout the lifecycle of a medicinal Product. Lead multidisciplinary or crossfunctional work/project teams; serve as part of strategic team(s) within the group/discipline.
• Experience implementing largescale initiatives and/or organizational changes (such as functional optimization).
• Credible technical/ functional expert; ability to provide technical/functional guidance/ coaching to indirect reports/peers.
• Ability to influence the external environment through interactions with regulators, trade associations, or professional societies.
• Drive quality into the business through proactive quality support, mentoring and/or coaching and consultation.

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/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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