Associate Director, Gxp External Engagement

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, GxP External Engagement plays a key role in supporting and contributing to the execution of the GxP External Engagement strategy as a member of the External Engagement team. This includes: 1) Ensuring that BMS is recognized by regulatory authorities and industry peers as a thought leader in the areas of innovation, science, technology, quality and compliance 2) Promoting an organizational risk-based mind-set through early actions on issues of potential impact to operations, supply, or quality compliance and 3) Promoting transparency in information sharing and excellence in quality through the monitoring of internal and external factors for potential impact to operations and products, including those from emerging regulations, guidance, evolving expectations and quality issues in the GxP space.
The Associate Director, GxP External Engagement will, in collaboration with the Lead, GxP External Engagement, help drive the strategy for External Engagement and will, on a tactical level, execute compliance and intelligence programs in a matrixed organization. This role will interact and collaborate extensively with teams and leaders across the BMS network.
Responsibilities:
The Associate Director, GxP External Engagement, shall apply strong leadership and interpersonal relationship skills to accomplish the following responsibilities that include, but are not limited to:
Compliance/Quality Surveillance

• In collaboration with Lead, GXP External Engagement, support the routine compliance surveillance activities to detect, monitor, collate and communicate global compliance trends which could impact GPS operations through leadership in the BMS Policy Evaluation and Regulatory Landscape process.
• Identify and engage with existing surveillance activities across BMS to ensure robustness and effectiveness of the program.
• Identify, interpret, assess, and communicate emerging surveillance of regulatory and compliance landscape through the timely authorship and review of FLASH Reports and Regulatory Surveillance Yammer postings.
• Collect, and analyze data from multiple internal sources and identify patterns, insights and trends and ensure appropriate actions are taken, as appropriate to mitigate.
• Support data-driven insights into compliance performance and opportunities for improvement.
• Advance compliance expertise at BMS by providing education, knowledge sharing and other modes of learning.

External Engagement

• Supporting the Lead, GxP External Engagement, effectively communicate the outcomes of External Engagement across the organization, and ensure a closed loop mechanism to drive company action and impact where needed.
• Timely identify and assess emerging topics/expectations to define the company's strategy and involvement.

• Benchmark best practices in the industry to continuously improve internal processes and systems for development and manufacturing.

• Actively participate in Trade association meetings to develop relationships and build intelligence on upcoming regulatory changes and emerging compliance expectations that impact Quality, Compliance & Operations functions. Communicate learnings through established processes and relationships across the network.

Requirements:

• Bachelor's degree in pharmaceutical sciences, regulatory affairs, engineering, biology, or other related discipline or equivalent combination of education and experience

• 7+ years of biopharmaceutical industry experience or combination of industry and health authority experience, health authority experience preferred

• Experience within regulatory agencies or the Bio/Pharmaceutical Industry, including leadership experience in Clinical Studies, Quality, Manufacturing, Regulatory and/or Product Development.
• Significant understanding and track record in dealing with international regulation and policy development processes of major regulatory agencies
• Understanding of technical areas related to pharmaceutical and/or biological manufacturing, clinical study, regulatory and or quality control/quality assurance processes
• Comprehensive understanding of one of more GxP areas and willingness to expand knowledge into other areas.
• Experience in global or regional clinical operations or biologic products is preferred

• 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
• Strong communication, collaboration, negotiation, problem solving and interpersonal skills. Has a proven track record of working across regulatory/industry boundaries to find common solutions and drive positive impact and benefits for patients
• 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.)
• Pragmatic approach with demonstrated ability to make sound, risk-based decisions
• Excellent oral and written communication skills.
• Ability to be flexible and adapt quickly to the changing needs of the organization
• Demonstrated high degree of independence with effective presentation and interpersonal skills to ensure a team-oriented approach

#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
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
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.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.