Associate Director - Quality Management Systems

Bristol-Myers Squibb - New Brunswick, NJ

Full-time - Senior

Hybrid - New Brunswick, NJ

1,001-5,000 employees

Chemical Manufacturing

About the position

The Associate Director - Quality Management Systems at Bristol-Myers Squibb is responsible for leading the governance controls business processes across the global organization. This role focuses on ensuring that processes are standardized, effective, and compliant with GxP regulatory requirements. The position involves engaging with various stakeholders to drive operational excellence and continuous improvement within the integrated Quality Management System (QMS).

Responsibilities

• Serve as Process Lead to support end-to-end Governance Controls business processes across the global organization.
• Ensure processes are standardized, remain in a state of control, and are both effective and efficient.
• Support process architectures of the integrated Quality Management System (QMS).
• Engage with process owners and local site/function process owners in designing and deploying QMS process improvements.
• Drive operational excellence, continuous improvement, and process maturity, ensuring compliance with GxP regulatory requirements.
• Maintain global processes, procedures, and training materials in compliance with Global GxP requirements.
• 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.
• Monitor process health, ensuring it is in a state of control, efficient, and effective, and develop action plans to remedy issues when necessary.
• 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.

Requirements

• 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.
• 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.
• 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.
• Influential leadership expertise and experience with senior-level interactions.
• Ability to work in a matrixed organization with a range of technically, culturally, and geographically diverse teams.

Nice-to-haves

• 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.

Benefits

• Competitive salary and benefits package.
• Opportunities for professional growth and development.
• Flexible work environment with hybrid work options.