Lead, GxP External Engagement
Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.
Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.
As a member of the newly formed External Engagement team, the GxP External Engagement Lead will play a key role in supporting and contributing to the execution of the GxP external engagement strategy. This will include: 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 GxP External Engagement Lead will, in collaboration with the Head of 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.
This position is part of the Global Quality Organization and will report to the Head of External Engagement, Regulatory Compliance and External Engagement.
Major Duties and Responsibilities
- Drive BMS's Global Regulatory Observation Evaluation program aimed at ensuring ongoing GxP compliance across the BMS network through sharing of regulatory inspection observations/findings, gap assessments, and risk-based approaches
- Identify and report critical and other significant compliance risks and gaps observed during audit activities, reporting gaps through an effective escalation process
- Develop and maintain a repository for findings and evaluations which allows for data analysis and trending
- Identify specific measures and KPIs to track and trend effectiveness of the evaluation program and outcomes for communication to leadership and Tier Councils
- Lead or participate as External Engagement representative in Quality and Compliance projects/improvements
- In collaboration with Head of External Engagement, support the routine compliance surveillance activities to detect, monitor, collate and communicate global compliance trends which could impact GPS operations
- Identify and engage with existing compliance surveillance activities across BMS to ensure robustness and effectiveness of the program.
- Identify, interpret, assess, and communicate emerging surveillance of regulatory and compliance landscape
- 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
- Oversee compliance surveillance databases, ensure functionality and utility of archival systems
- Supporting the Head of 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 association meetings to develop relationship and build intelligence on upcoming regulatory changes and emerging compliance expectations that impact Quality, Compliance & Operations functions
- 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)
- Six Sigma, ASQ or similar certifications 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
- 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
- Comprehensive understanding of one of more GxP areas and have willingness to expand knowledge into other areas.
- 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.)
- Demonstrated strong leadership capability with ability to make and act on decisions while balancing speed, quality and risk to deliver value added business results that meet high quality requirements with tight deadlines
- Pragmatic approach with demonstrated ability to make sound, risk-based decisions
- Excellent oral and written communication skills.
- Develop enterprise mindset and ability to navigate cross-functionally
- Develop subject matter expertise in various GxP process areas
- Develop continuous improvement mindset
- Develop leadership and communication capabilities
- Gain responsibility for operational improvements
- Gain exposure to executives across different functions
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 the resources to pursue their goals, both at work and in their personal lives.