Director of Global Quality & GMP Operations

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.

• Define and execute the site Quality Strategy, aligned with global business objectives and regulatory expectations.
• Serve as a key member of the site leadership team, influencing risk-based decision-making and operational excellence.
• Foster a strong quality culture, promoting accountability, transparency, and continuous improvement across all functions.
• Lead, coach, and develop the Quality organization, ensuring capability building and succession planning.
• Liaise with the global Infection Prevention team, marketing/sales organization, R&D and other internal customers to ensure that the existing Pharmaceutical Quality requirements are known and controlled at the plant and at critical suppliers.
• Provides project support for key deliverables and partners with regional representatives for the global expansion of the product portfolio.
• Demonstrates forward thinking leadership that drives continuous proactive engagement of the QA team.
• Collaborates with R&D department to transfer new design engineering products into manufacturing.
• Manages inspection of readiness programs and activities for the site, ensuring an inspection ready state.
• Proactively assess quality issues to determine impact in the field and ensures they are addressed in a timely manner.
• Proactively engage with appropriate teams to secure the GMP certification of the site as well as those of critical suppliers.
• As the management representative, establishes and maintains a Quality Management System to ensure the manufacturing facility, analytical laboratory, warehouse and distribution and other functional areas remains fully compliant with Good Manufacturing Practices and other applicable global regulatory requirements.
• Ensures GMP compliance of products, including defining applicable manufacturing quality standards, establishing appropriate testing methods and procedures, establishment/support of manufacturing and engineering requirements to improve design for manufacturability, deviations and reworks when applicable.
• Ensure all products meet identity, strength, quality, and purity requirements prior to release.
• Provide final Quality approval for batch disposition in compliance with GMP requirements.
• Ensure appropriate laboratory controls, specifications, and testing strategies are scientifically sound and compliant (aligned to 21 CFR 211.160).
• Assumes global responsibility for Qualified Personnel communication and support.
• Provides timely support when requested by all global organizations in supporting the preparation of necessary quality documents to support the Infection Prevention platform products.
• Manages product and process quality reports/metrics collecting, analyzing, and summarizing information and trends and proactively driving improvements.
• Plans, coordinates, leads and facilitates internal and external audits and provides leading role support during Health Authority inspections. Ensures the necessary response efforts for inspections are executed per requirements and timelines.
• Manages timely and robust execution of all QMS elements including change control, CAPA, complaint investigations, out of specification investigations, out of trend investigations, non-conformances, and training compliance.
• Complies with all Business Unit and Corporate policies, standards, and procedures.
• Drive timely, thorough, and scientifically sound investigations, ensuring appropriate root cause identification and effective CAPA implementation.
• Ensure data integrity principles (ALCOA+) are embedded across all quality systems.
• Ensure continuous compliance with FDA, EMA, and other global health authority requirements.
• Lead regulatory inspections (FDA, Notified Bodies, MHRA, etc.) and ensure high-quality, timely responses to observations.
• Maintain the site in…