Director, Operations Quality, El Paso

About BD 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™. Our purpose is to transform the impossibility into possibilities through design, engineering, manufacturing, and marketing of MedTech products. Job 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. Provide project support for key deliverables and partner with regional representatives for the global expansion of the product portfolio. Demonstrate forward‑thinking leadership that drives continuous proactive engagement of the QA team. Collaborate with R&D department to transfer new design engineering products into manufacturing. Manage 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 ensure 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. Quality Site Lead As the management representative, establish and maintain a Quality Management System that ensures full compliance with Good Manufacturing Practices and other applicable global regulatory requirements across all functional areas. Ensure GMP compliance of products, including defining appropriate manufacturing quality standards, testing methods, and procedures, and supporting engineering requirements to improve design for manufacturability, deviations and reworks. 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 with 21 CFR 211.160. Assume global responsibility for qualified personnel communication and support. Provide timely support when requested by all global organizations in preparing quality documents for the Infection Prevention platform products. Manage product and process quality reports/metrics, collecting, analyzing, and summarizing information and trends and proactively driving improvements. Plan, coordinate, lead and facilitate internal and external audits and provide leading role support during Health Authority inspections. Manage 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. Comply with all Business Unit and Corporate policies, standards, and procedures. Drive thorough and scientifically sound investigations, ensuring appropriate root‑cause identification and effective CAPA implementation. Embed data integrity principles (ALCOA+) across all quality systems. Regulatory Compliance & Inspection Readiness 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 a constant state of inspection readiness. Act as the primary quality interface with regulatory authorities. Manufacturing & Technical Partnership Partner with Manufacturing, Engineering, and R&D to ensure process robustness and validation lifecycle compliance. Support technology transfers and new product introductions (NPI). Drive continuous improvement initiatives. Risk Management & Product Impact Assessment Lead risk assessments related to product quality and patient safety, including field impact evaluations, recall decision‑making, and health hazard assessments. Ensure timely escalation and management of critical quality issues. Education and Experience Bachelor’s degree in Science, Engineering, or related discipline (required). Advanced degree (MS, MBA, or equivalent) preferred. Minimum 10 + years of experience in regulated pharmaceutical industry. Minimum 5 + years in leadership roles within Quality. Demonstrated experience managing regulatory inspections and responses. Strong knowledge of global regulatory requirements and GMP systems. Knowledge & Skills Expert knowledge of: 21 CFR Parts 210/211/820 EU GMP (including Annex 1) ICH Guidelines (Q7, Q9, Q10) Data Integrity requirements (FDA, MHRA, PIC/S) OOS: EU Directive 2001/83/EC and Regulation (EC) No 726/2004 and Annex 1‑16. Strong expertise in: General: Pharmaceutical Transport Regulations. Sterility assurance and microbiological control (if applicable). Validation lifecycle (process, cleaning, equipment), including laboratory systems/equipment. Investigations and root cause analysis. Effectively review/critique technical documents such as lab investigations with analytical, manufacturing, and regulatory content. Proven ability to: Lead through influence in a matrix organization. Make risk‑based, science‑driven decisions. Communicate effectively with executive leadership and regulators. Leadership Competencies Strategic thinking and execution. Strong decision‑making under pressure. Talent development and team leadership. Effective written and verbal communication. High level of integrity, accountability, and ownership. Negotiation and strong persuasive abilities, diplomacy, and positive influencing abilities. Additional Requirements Ability to operate in a fast‑paced, highly regulated environment. Strong organizational and prioritization skills. Bilingual (English/Spanish) preferred. Travel requirement: ~20 % (domestic and international). Physical Demands Position requires sitting or standing for long hours. Work Environment Manufacturing. Equal Opportunity Employer Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectionate or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics. Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectionate or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. #J-18808-Ljbffr