Associate Director - Quality Management Systems

Bristol-Myers Squibb-posted about 1 year ago

Full-time • Senior

Hybrid • Summit, NJ

Chemical Manufacturing

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The Associate Director - Quality Management Systems at Bristol Myers Squibb will serve as the Process Lead to support end-to-end Governance Controls business processes across the global organization. This role is crucial for ensuring that processes are standardized, effective, and efficient while maintaining compliance with GxP regulatory requirements and BMS Quality standards. The position involves engaging with various stakeholders to drive operational excellence and continuous improvement within the integrated Quality Management System (QMS).

Maintain global processes, procedures, and training materials in compliance with Global GxP requirements.
Drive optimal execution of processes across BMS and external partners.
Identify and prioritize quality process & system improvements.
Provide training, support, and coaching as required.
Define process monitoring methods, including data collection and analysis, metrics, and associated targets.
Define and lead the development of metrics through standard queries and reports with system functionality.
Monitor process health, ensuring it is in a state of control, efficient, and effective, and develop action plans to remedy issues when necessary.
Navigate cross-functional teams through ambiguity towards clear and actionable decisions.
Support development and execution of operational excellence and continuous improvement projects.
Identify and track progress against key project milestones, partnering with applicable business and quality teams to ensure overall project success.
Engage leadership from business case development through program delivery, ensuring organizational alignment on scope, schedule, quality, and benefits.
Participate/lead regulatory surveillance and benchmarking initiatives to stay abreast of changes in regulations affecting QMS processes.
Support site and function teams during regulatory inspections or audits.
Serve on systems project teams and committees to ensure timely accommodation of system issues and opportunities.
Support the global process during audits and inspections.

Minimum of a bachelor's degree in a related field (advanced degree preferred).
10+ years of experience in a pharmaceutical/biotechnology/advanced therapeutic modality products (ATMP) environment (e.g., research, analytical, quality, engineering, manufacturing, regulatory CMC, or IT).
Knowledgeable of GxP regulations and expectations for core health agencies; thorough understanding of regulatory requirements in relation to QMS.
Familiar with electronic quality system tools.
Strong program and project management experience with a proven track record of managing cross-functional programs and the ability to manage multiple, simultaneous projects.
Familiarity with developing and executing organizational change, including change management strategy and planning.
Strong problem-solving and analytical skills with the ability to analyze data, performance metrics, assess risks, identify trends, and develop mitigation strategies and improvement opportunities.
Influential leadership expertise and experience with senior-level interactions.
Enterprise mindset to think and act across functions and divisions.
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.
Strong strategic thinking capability with a strong project management focus.
Strong leadership capability with the ability to make and act on decisions while balancing speed, quality, and risk.
Change agility in anticipating and leading others through change and ambiguity.
Innovation, flexibility, open-mindedness, and adaptability to meet objectives in a rapidly changing environment with shifting priorities.
Ability to communicate with presence and influence in both formal and informal settings, preparing and presenting persuasive written and verbal materials with employees and management at all levels.
Ability to set priorities and deliver results without constant feedback/input from the manager.
Ability to identify, manage, and/or escalate issues and risks to timelines.
Enable QMS alignment with business strategy and ensure business strategy is executed at the process level as aligned with the global process owner.
Ensure standardization and prioritization of accountable processes at the global level.
Enable an enterprise mindset and drive cross-function/cross-site collaboration.

Competitive salary and benefits package
Opportunities for professional development and career growth
Flexible work environment
Diversity and inclusion programs
Health and wellness programs

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