Senior Director, Competitive Compliance (Corporate Quality)

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. Read more: careers.bms.com/working-with-us.

Position Summary

Reporting to the Vice President, Corporate Quality, this role provides strategic and tactical direction for the GPS divisional audit program for product development, clinical supplies, manufacturing, and product distribution across all modalities including CMOs, CLOs, material suppliers and service providers, inclusive of IT systems and services. Leads inspectional readiness activities across the network inclusive of biologics, small molecule and cell therapy as well as distributors and local markets inclusive of global regulatory agencies worldwide. Serves as consultancy to sites/functions with regulatory inspections including Pre-inspection readiness.

Key Responsibilities

·       Responsible for development of risk-based process for assessment of sites, suppliers and contract providers across all modalities and vendor types ensuring inspection readiness strategies and risk mitigation across the enterprise.

·       Responsible for the execution of strategic audit plan and identification of emerging risk.

·       Development of Inspection Readiness strategy that provides standardized end-to-end approach to inspection preparedness that can be leveraged by the BMS network.

·       Collaborate to Identify emerging internal and external compliance indicators to proactively inform inspection readiness strategy. 

·       Partners with business to accommodate ad-hoc audits based on performance or changes in business needs.

·       Responsible for management of risk-based audit program across all modalities and vendor types.

·       Partners with business units and functions to drive remediations of audit outcomes with a lens towards enterprise performance and patient supply.

·       Serves as consultancy to sites/functions with regulatory inspections including pre-inspection readiness as well as regulatory inspection responses for complex compliance matters.

·       Assist with regulatory notifications, including assuring appropriate and consistent standards are in place

·       Works closely with legal to ensure robust and appropriate communications with external regulators globally.

·       Support site and function teams during regulatory inspections or audits, which may include direct interface with inspectors/auditors and writing/reviewing responses.

·       Continuous improvement across R&D and GPS quality metrics defined by GxP requirements.

Qualifications & Experience

·       Minimum of a bachelor’s degree in scientific discipline.

·       15 plus years’ experience in the pharmaceutical industry.

·       Thorough understanding of regulatory requirements across multiple modalities inclusive of GMP, GDP and IT/Data Integrity Requirements.

·       Profound understanding of international GxP regulations and policies setting processes of major regulatory agencies (e.g., US FDA, EU, WHO).

·       Quality operational experience to ensure understanding of key business quality and compliance drivers of the Pharmaceutical Industry.

·       Strong communication, negotiation, problem solving, and interpersonal skills.

·       Demonstrated strong leadership capability with ability to make and act on decisions while balancing speed, quality and risk.

·       Demonstrated change agility and leading others through change and ambiguity.

·       Ability to provide innovative ideas or alternatives that create.

·       High organization awareness (e.g., interrelationship of departments, business priorities), including significant experience working cross-functionally and in global teams.

·       Demonstrated ability to work effectively in a matrix environment and drive results through "influence" as well as direct management.

·       Demonstrated Enterprise mindset to be able to think and act across functions and divisions.

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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 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 [email protected]. 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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