Executive Director, Compliance Enabling QMS
4 months ago
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.
Position Summary
Reporting to the Vice President, Corporate Quality, this role is primary responsible for the development, management and oversight of the End-to-End Quality Management system inclusive of R&D Operations and Global Pharmaceutical Sciences driving compliance at the site and functional levels across all GxP areas covering cell therapy, biologics and small molecules. Additional ownership of core quality systems including Investigation, Deviation, CAPA Management, Change Control, Risk Management, Audit/Inspection, Training, and other quality system processes, as needed. Responsible for continuous improvement cycles relates to the QMS and ensuring capabilities of the business to implement the QMS.
Key Responsibilities
Responsible for implementing and maintaining The Quality Management System (QMS) across R&D and GPS ensuring continuous improvement for the associated Quality Systems and implementing strategy at the enterprise level.
Ensures adherence to phase appropriate cGxP compliance requirements, in compliance with FDA, EU and global regulations and ICH guidelines.
Effectively collaborates with sites and functions across the company to analyze and resolve issues in accordance with appropriate quality standards ensuring a fit for purpose model across the enterprise.
Stay informed of evolving regulatory requirements and industry trends related to quality management systems, and proactively assess their impact on the organization. Define, enhance and maintain GPO network to drive strategic GPS objectives.
Support BMS M&A activities by ensuring alignment across the QMS framework
Foster a culture of quality excellence by promoting awareness, training, and engagement across the organization, emphasizing the importance of quality in all aspects of our operations.
Collaborate with senior leadership to develop and execute quality strategies that align with business objectives and drive continuous improvement in quality performance.
Qualifications & Experience
Bachelor’s Degree or equivalent education and 15+ years of experience. Master’s degree preferred.
Must have experience working in the pharmaceutical industry with the FDA, EMEA and preferably multiple additional regulatory agencies in other foreign countries. Experience working in Regulatory Law is a plus.
Must have experience working at an enterprise level engaging with executive business leadership. Plant/site experience is also desired.
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 competitive advantages across enterprise
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.
#LI-HYBRID
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 . Visit 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.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
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