Associate Director, Quality Management

About BD

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of Med Tech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

We are the makers of possible. BD is a global medical technology company that advances health solutions. Join us in an environment where you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.

Associate Director, Quality Management – Site Quality Leader. Oversee multiple quality functions including Quality Assurance, Quality Control, Quality Systems & Compliance, and Quality Engineering for Pharmaceutical Systems and BDX Molding Center of Excellence. Report to the Senior Director of Quality Operations and serve as a key member of the site leadership team while contributing to worldwide functional strategy and priorities.

• Strategic Leadership:
  Develop and maintain comprehensive plant quality and compliance strategies, policies, and frameworks that drive organizational excellence and regulatory adherence.
• Team Development:
  Lead, coach, and develop a high‑performing quality team, fostering professional growth while building a cohesive department that maintains strong quality presence across manufacturing areas.
• Regulatory Interface:
  Serve as the plant "management representative" for notified bodies, regulatory authorities, and customers, managing audits and ensuring effective resolution of findings.
• Cross‑Functional
  
  Collaboration:
  
  Build influential networks with worldwide Quality and Regulatory functions, other plant Quality Leaders, and key global functions (R&D, Engineering, Supply Chain) to ensure alignment around priorities.
• Quality Systems Management:
  Direct operational leadership in planning and managing comprehensive quality systems, including:
  • Validation programs
  • Internal and customer quality audits
  • Compliance audits
  • Corrective and preventive action programs (CAPA)
  • GMP training initiatives
  • Quality engineering
  • Change control processes
  • Document control systems
  • Complaint management
• Continuous Improvement:
  Identify quality improvement opportunities within operations and partner with peers in Manufacturing, Engineering, and Supply Chain to develop and implement innovative solutions.
• Resource Management:
  Ensure the quality organization is properly staffed, organized, and resourced to fulfill cGMP obligations and BD procedures.
• Cultural Transformation:
  Champion and promote a culture of quality excellence throughout the plant, driving organizational change that elevates quality standards.

• Required:
  
  Bachelor's degree in a technical or science‑related field
• Preferred:
  Advanced degree in a technical or science‑related discipline

• 10+ years of experience in pharmaceutical/biopharmaceutical manufacturing environments (highly preferred)
• 10+ years in plant Quality leadership roles with demonstrated success (highly preferred)
• Comprehensive knowledge of 21
  
  CFR parts 820 (QSR), 210/211, ISO
  9001, 13485 with experience leading or participating in related audits and inspections
• Experience in production or engineering management (preferred)
• Multi‑country/multi‑cultural experience (preferred)

• Technical Expertise:
  Proficiency with quality management systems and tools including SAP, Trackwise, MS Office, Minitab, and SAS
• Leadership:
  Demonstrated courage in making difficult decisions and driving organizational change
• Change Management:
  Proven ability to lead teams through transformational initiatives
• Communication:
  Exceptional verbal and written communication skills with the ability to influence across organizational levels
• Problem‑Solving:
  Strong analytical thinking and data‑driven decision‑making capabilities
• Adaptability:
  Learning agility and flexibility in responding to evolving business needs
• Strategic Vision:
  Ability to connect daily operations to long‑term organizational goals