Director, External Engagement Insights Integrator

Bristol-Myers Squibb - New Brunswick, NJ

Full-time - Senior

Hybrid - New Brunswick, NJ

Chemical Manufacturing

About the position

The Director, External Engagement Insights Integrator at Bristol-Myers Squibb plays a crucial role in supporting and implementing the GxP external engagement strategy. This position is responsible for ensuring the company is recognized as a thought leader in quality and compliance, promoting a risk-based mindset, and maintaining high standards of quality. The role involves developing external engagement strategies, representing the company at industry events, and collaborating with cross-functional teams to align external engagement opportunities with business objectives.

Responsibilities

• Serve as a key individual contributor in supporting and implementing the GxP external engagement strategy.
• Ensure BMS is recognized by regulatory authorities and industry peers as a thought leader in quality and compliance.
• Promote an organizational risk-based mindset through early actions on potential operational impacts.
• Encourage proactive information sharing and maintain high quality standards by monitoring internal and external factors affecting product quality.
• Support the development of a comprehensive external engagement strategy aligned with BMS's business objectives.
• Identify and evaluate emerging trends to shape the company's strategy and engagement.
• Plan and execute external engagement activities, ensuring alignment with regulatory requirements.
• Represent the company at major trade organizations and industry conferences to advocate for BMS's interests.
• Collaborate with cross-functional teams to prioritize external engagement opportunities.
• Support routine compliance surveillance activities to monitor global compliance trends.
• Communicate outcomes of external engagement across the organization to drive action and impact.
• Develop clear presentations for the Quality Council summarizing regulatory updates and recommended actions.
• Leverage data to gain insights into potential risks and regulatory requirements.
• Integrate external insights into overall quality data to proactively identify risks and implement mitigation strategies.
• Benchmark best practices in the industry to improve internal processes and systems.
• Engage actively in association meetings to build intelligence on regulatory changes.

Requirements

• Bachelor's degree in pharmaceutical sciences, regulatory affairs, engineering, biology, or related discipline.
• 10 years of biopharmaceutical industry experience or a combination of industry and health authority experience.
• Extensive experience within regulatory agencies or the Bio/Pharmaceutical Industry, including leadership experience in Quality, Manufacturing, Regulatory, and/or Product Development.
• Direct experience leading GxP compliance activities is required.
• Significant understanding of international regulations and policies from major regulatory agencies.
• Demonstrated ability to work in a matrixed organization and influence diverse teams.
• Strong communication, collaboration, negotiation, problem-solving, and interpersonal skills.

Nice-to-haves

• Experience with health authority regulations and compliance expectations.
• Familiarity with quality metrics and auditing processes.

Benefits

• Competitive salary
• Comprehensive health insurance
• 401k retirement plan
• Flexible work environment
• Professional development opportunities