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Senior Vice President, Head of Quality Assurance

2 months ago

Princeton, New Jersey, United States Bristol-Myers Squibb Company Full time

About Us

At Bristol Myers Squibb, we believe in the power of meaningful work. Our environment is one where challenging tasks lead to life-changing outcomes, not just for our patients but also for our employees. Each day presents unique opportunities to contribute to groundbreaking advancements in medicine, from enhancing production processes to pioneering cell therapy innovations. Here, you will find the chance to develop your career in ways that are both profound and fulfilling, working alongside diverse and high-performing teams.

Bristol Myers Squibb values the significance of work-life balance and flexibility. We provide a comprehensive range of competitive benefits and programs designed to support our employees in achieving their professional and personal aspirations.

The Head of Quality Assurance will report directly to the Executive Vice President of Global Product Development & Supply Chain and will also maintain a close relationship with the CEO and the Board of Directors. This role is pivotal in delivering long-term strategic insights related to quality that align with BMS's business goals. The individual will oversee quality and compliance across the organization, including Research & Development and the Global Product Supply network, while managing global testing facilities and audit teams.

Key Responsibilities

  • Serve as a member of the Global Product Supply Leadership Team and act as the Company’s Quality Officer.
  • Maintain close collaboration with the BMS Leadership Team and Board of Directors.
  • Provide strategic leadership for the entire Quality chain, both internally and externally.
  • Implement and uphold the BMS Quality System across commercial and R&D sectors.
  • Foster a Culture of Excellence throughout the organization.
  • Standardize quality systems and processes across Biologics, Pharmaceuticals, Cell Therapy, and Radiopharmaceuticals while ensuring adaptability to meet specific business needs.
  • Develop a world-class audit program for both R&D and commercial supply chains, covering internal and external manufacturing sites.
  • Ensure compliance with the Quality Management System across all development and manufacturing processes, including the approval of the Annual Audit Plan.
  • Oversee the validation, transfer, and lifecycle management of analytical methods.
  • Manage reporting to regulatory agencies and address product quality complaints.
  • Establish and monitor metrics that promote proactive quality and compliance.
  • Ensure timely communication of quality escalations to management and implement necessary actions.
  • Lead the Quality Council and Product Review Committee for quality-related issues, as well as the Investigational Review Committee.
  • Build and maintain a professional network, staying informed on external market practices and positioning oneself as an industry influencer through participation in strategic forums.

Qualifications & Experience

  • Proven leader in the biopharmaceutical sector with over 20 years of experience in quality management, demonstrating a successful track record in overseeing end-to-end quality and compliance across R&D and manufacturing.
  • Ability to cultivate and lead a team of professionals across various organizational levels.
  • A Bachelor's degree is required; a Master's or PhD is preferred.
  • Significant experience in interactions with regulatory bodies such as the FDA and EMA.
  • Recognized thought leader within the industry.

Company Commitment

Bristol Myers Squibb is dedicated to fostering an inclusive environment where every employee can thrive. We are committed to ensuring that individuals with disabilities have equal opportunities and support throughout the recruitment process and in their roles. We also prioritize the health and safety of our employees and communities, strongly recommending that all staff members stay up to date with vaccinations.

Bristol Myers Squibb is an equal opportunity employer, and we welcome applications from qualified individuals regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.