Director, Global Biopharmaceutical Stability Operations

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Position Summary
The Director, Global Biopharmaceutical Stability Operations drives integration of process and procedures within the Global Biopharmaceutical Stability Group. This position serves to ensure effectiveness and efficiency of the global commercial stability Level 2 process within the QMS framework. This position evaluates and improves upon, and generates, as necessary, trending processes and systems in support of the entire Bristol Myers Squibb commercial product portfolio (biologics & small molecule). This position leads external engagement activity, including support for regulatory surveillance and participating with external communities. Additionally, this position will have team oversight for the implementation and improvement of Data Integrity requirements and Quality Risk Management tools.
This position is also accountable for the execution of the commercial stability storage and logistics operations across the entire Bristol Myers Squibb network including management the daily oversight of sample pulls, set downs, documentation and the definition and oversight of our commercial stability storage strategy. This position has oversight of the implementation and management of electronic systems as applied to the Global Biopharmaceutical Stability team, including Laboratory Information Management Systems.
This role will combine leadership, collaboration, optimization, global strategy development, and innovative thinking to drive the continuing evolution of the Global Biopharmaceutical Stability team as the Bristol-Myers Squibb Stability Center of Excellence.

Key Responsibilities:

• Serves as the commercial stability Global Process Owner (GPO) providing leadership for program governance, operations, escalations, and benefits realization with respect to the QMS and global Stability Level 2 processes and systems.

• Collaborates with QMS pillar ownership, Level 1 process leads, and network GPOs, Global Process Leads, and Local Process Owners to ensure the QMS as a quality business advantage.

• Drives continuing QMS refinement within the commercial Stability Level 2 network toward a more simplified, aligned, and agile global process.

• Drives operational excellence initiatives within the Global Biopharmaceutical Stability team and the Global Stability Level 2 network to ensure continuous improvement, innovation, and simplification of QMS processes and procedures to support Quantum Leap.

• Leads and oversees assignment and assessment of regulatory surveillance via the External Engagement process and ensures implementation of resulting requirements and guidance.

• Oversees the evolution and maturation of the commercialization procedure in order to provide efficient and agile processes to stability product leads for new product and process introductions.

• Owns the global Stability Level 2 communities of practice to collaborate and align on a future state process and procedures that will support fit-for-purpose and fit-for-speed execution in context of Quantum Leap.

• Manages day-to-day operations of stability sample management, logistics, and enrollment across the Global Biopharmaceutical Stability network, inclusive of internal and external partners, to ensure uninterrupted sample availability and supply in support of commercial stability regulatory requirements.

• Oversees and defines the commercial stability storage strategy to generate aligned, harmonized, or standardized operational requirements supporting risk reductions, business continuity, cost effective capacity and resource management, and efficient and compliant storage program strategies.

• Ensures all critical and major issues, which may have an adverse effect on the quality of the pro