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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 .

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, 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.

Education and Experience required :

• · Bachelor's degree in pharmaceutical sciences, regulatory affairs, engineering, biology, or other related discipline or equivalent combination of education and experience · 10 years of biopharmaceutical industry experience or combination of industry and health authority experience (health authority experience, preferred) · Extensive experience within regulatory agencies or the Bio/Pharmaceutical Industry, including significant leadership experience in Quality, Manufacturing, Regulatory and/or Product Development. · Direct experience leading and supporting one or more GxP compliance activities is required. · Significant understanding and track record in dealing with international regulations and policies setting processes of major regulatory agencies. · 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 regulator/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.) · Must have a comprehensive understanding of one of more GxP areas and have willingness to expand knowledge into other areas.

#BMSBL

#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

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 adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) 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.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Company: Bristol-Myers Squibb

Req Number: R1587557

Updated: 2024-11-28 02:30:48.183 UTC

Location: Dublin-IE

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.