Director, External Engagement Insights Integrator
vor 2 Wochen
**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.
As the lead of GxP External Engagement, the Insight Integrator will serve as a key individual contributor, playing a vital role in supporting and implementing the GxP external engagement strategy.
This will include:
- Ensuring that BMS is recognized by regulatory authorities and industry peers as a thought leader in the areas of quality and compliance
- Promoting an organizational risk-based mind-set through early actions on issues of potential impact to operations, supply, or quality compliance and
- Encouraging proactive and transparent information sharing and maintaining a high standard of quality by monitoring both internal and external factors that may affect product quality. This includes staying updated on emerging regulations, guidance, evolving expectations, and quality issues within the GxP space.
- Support the development of a comprehensive external engagement strategy aligned with the BMS's business objectives and values.
- Proactively identify and evaluate emerging trends and expectations to shape the company's strategy and engagement.
- Support the planning and execution of external engagement activities, such as conferences and presentations, ensuring their alignment with regulatory requirements and compliance standards.
- Represent the company on major trade organizations
- for example PhRMA or EFPIA
- Represent the company at industry conferences, meetings, and other events to stay informed and advocate for the company's interests, while building and maintaining strong relationships with key external stakeholders, including industry associations and other relevant organizations.
- Collaborate with cross-functional teams to identify and prioritize external engagement opportunities that align with the company's strategic priorities.
- In partnership with QRM, the Insight Integrator will provide support for routine compliance surveillance activities. These activities aim to detect, monitor, collate, and communicate global compliance trends that have the potential to impact GPS operations.
- In collaboration with the head of Corporate Quality, effectively communicate the outcomes of external engagement across the organization and ensure a closed loop mechanism to drive company action and impact where needed.
- Develop and provide clear, concise, and informative presentations for the Quality Council, summarizing regulatory updates, potential impacts, and recommended actions.
- The Insight Integrator will leverage data (e.g., Redica) to gain valuable insights into potential risks and regulatory requirements. By analyzing and interpreting data, the Insight Integrator will be able to identify patterns, trends, and potential areas of concern.
- In collaboration with our partners, will integrate external insights, including Redica data, into our overall quality data, encompassing QRM, Quality Metrics, Auditing, and Inspection readiness. Enabling our ability to proactively identify risks and implement robust mitigation strategies and ensure compliance with relevant regulations.
- Effectively benchmark best practices in the industry to continuously improve internal processes and systems for development and manufacturing.
- Support PEARL through active engagement by ensuring applicable assessments are completed, outcomes and actions are documented, and process performance and major signals are reported at the Quality Council to ensure awareness, track progress, and facilitate necessary actions to address risks.
- Effectively benchmark best practices in the industry to continuously improve internal processes and systems for development and manufacturing.
- Actively participate in association meetings to develop relationship and build intelligence on upcoming regulatory changes and emerging compliance expectations that impact Quality, Compliance & Operations functions
- Thorough understanding of policies and regulatory requirements, and their relation to the management and documentation of product quality
- Understanding of technical areas related to pharmaceutical and/or biological manufacturing, regulatory and quality control/quality assurance processes
- In collaboration with the head of Corporate Quality, effectively communicate the outcomes of external engagement across the organization and ensure a closed loop mechanism to drive company action and impact where needed.
- Develop and provide clear,
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