Bristol-Myers Squibb - Summit, NJ

posted 3 days ago

Full-time - Senior
Hybrid - Summit, 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 that the company is recognized as a thought leader in quality and compliance by regulatory authorities and industry peers. The role involves promoting a risk-based mindset, monitoring internal and external factors affecting product quality, and developing a comprehensive external engagement strategy aligned with business objectives. The Insight Integrator will also represent the company at industry conferences and collaborate with cross-functional teams to prioritize engagement opportunities.

Responsibilities

  • Support and implement the GxP external engagement strategy.
  • Ensure BMS is recognized as a thought leader in quality and compliance.
  • Promote a risk-based mindset through early actions on potential operational impacts.
  • Encourage proactive information sharing and maintain high quality standards.
  • Stay updated on emerging regulations and quality issues in the GxP space.
  • Develop a comprehensive external engagement strategy aligned with BMS's objectives.
  • Identify and evaluate emerging trends to shape company strategy.
  • Plan and execute external engagement activities, ensuring compliance with standards.
  • Represent the company at major trade organizations and industry events.
  • Collaborate with cross-functional teams to prioritize engagement opportunities.
  • Support compliance surveillance activities to monitor global compliance trends.
  • Communicate outcomes of external engagement across the organization.
  • Develop presentations for the Quality Council summarizing regulatory updates and impacts.
  • Leverage data to gain insights into potential risks and regulatory requirements.
  • Benchmark best practices in the industry to improve internal processes.
  • Engage 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 equivalent combination of industry and health authority experience.
  • Extensive experience within regulatory agencies or the Bio/Pharmaceutical Industry.
  • Significant leadership experience in Quality, Manufacturing, Regulatory, or Product Development.
  • Direct experience leading GxP compliance activities.
  • Strong understanding of international regulations and policies.

Nice-to-haves

  • Experience in a matrixed organization with diverse teams.
  • Proven track record of working across regulatory and industry boundaries.
  • Ability to communicate effectively with employees and management at all levels.

Benefits

  • Competitive salary
  • Flexible work environment
  • Comprehensive health benefits
  • Retirement savings plan
  • Professional development opportunities
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