Associate Director, GxP External Engagement
Posted on Apr 5, 2021 by Bristol-Myers Squibb
At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science. In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
Principle Objective of Position
As a member of the External Engagement team, the Associate Director, GxP External Engagement plays 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 Associate Director, GxP External Engagement will, in collaboration with the Lead, GxP 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 Lead, GxP External Engagement.
Major Duties and Responsibilities
The Associate Director, GxP External Engagement, shall apply strong leadership and interpersonal relationship skills to accomplish the following responsibilities that include, but are not limited to:
In collaboration with Lead, GXP External Engagement, support the routine compliance surveillance activities to detect, monitor, collate and communicate global compliance trends which could impact GPS operations through leadership in the BMS Policy Evaluation and Regulatory Landscape process.
Identify and engage with existing surveillance activities across BMS to ensure robustness and effectiveness of the program.
Identify, interpret, assess, and communicate emerging surveillance of regulatory and compliance landscape through the timely authorship and review of FLASH Reports and Regulatory Surveillance Yammer postings.
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.
Supporting the Lead, GxP 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 companys strategy and involvement.
Benchmark best practices in the industry to continuously improve internal processes and systems for development and manufacturing.
Actively participate in Trade association meetings to develop relationships and build intelligence on upcoming regulatory changes and emerging compliance expectations that impact Quality, Compliance & Operations functions. Communicate learnings through established processes and relationships across the network.
Bachelors degree in pharmaceutical sciences, regulatory affairs, engineering, biology, or other related discipline or equivalent combination of education and experience
7+ years of biopharmaceutical industry experience or combination of industry and health authority experience
Experience within regulatory agencies or the Bio/Pharmaceutical Industry, including leadership experience in Clinical Studies, Quality, Manufacturing, Regulatory and/or Product Development.
Significant understanding and track record in dealing with international regulation and policy development processes of major regulatory agencies
Understanding of technical areas related to pharmaceutical and/or biological manufacturing, clinical study, regulatory and or quality control/quality assurance processes
Comprehensive understanding of one of more GxP areas and willingness to expand knowledge into other areas.
Experience in global or regional clinical operations or biologic products is preferred
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 (eg presentations, written proposals, reports, correspondence, lead meetings, face-to-face dialogue, etc.)
Pragmatic approach with demonstrated ability to make sound, risk-based decisions
Excellent oral and written communication skills.
Ability to be flexible and adapt quickly to the changing needs of the organization
Demonstrated high degree of independence with effective presentation and interpersonal skills to ensure a team-oriented approach
May require travel up to 10%