Sr. Director, Operations Quality Management

Benefits

Additional Information

We are the people who give possibilities purpose 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 MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. Job Description We are the makers of possible 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 MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us. Job Summary: The Sr. Director of Operations Quality Management is responsible for leading and overseeing all Quality functions at the site, ensuring full compliance with applicable regulatory requirements (e.g., 21 CFR Parts 210, 211, 820; EU GMP; ICH guidelines) and internal global standards for the El Paso, TX Site. This role provides strategic leadership for the Quality Management System (QMS), ensuring consistent delivery of safe, effective, and compliant products. The position serves as the site Quality Head and Management Representative, with accountability for product quality, regulatory compliance, inspection of readiness, and continuous improvement of quality systems and processes. Lead and manage warning letter and broader regulatory remediation situations, including response strategy, cross-functional remediation governance, health authority commitments, and sustained execution to restore and maintain compliance. Job Responsibilities: Main Responsibilities Strategic Leadership & Quality Culture 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 Ensure Pharma quality requirements that affect operational activities are adequately implemented in the design aspects of the product 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 assesses quality issues to determine impact in the field and ensures they are addressed in a timely manner. Proactively engages with appropriate teams to secure the GMP certification of the site as well as those of critical suppliers. Ensures active engagement, participation and partnership in pharmacovigilance activities and OUS quality related activities. Quality Site lead 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 (as required) remains fully compliant with Good Manufacturing Practices and other applicable global regulatory requirements as applicable to pharmaceutical manufacturing. 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/if 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