Sr. Director, Operations Quality Management

Becton Dickinson Medical Devices•El Paso, TX

1d•Onsite

About The Position

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.

Requirements

Bachelor’s degree in Science, Engineering, or related discipline (required)
Minimum 10+ years of experience in regulated pharmaceutical industry required
Minimum 5+ years in leadership roles within Quality
Demonstrated experience managing regulatory inspections and responses
Strong knowledge of global regulatory requirements and GMP systems
Oversight and understanding of chemical and microbiological activities in an operational role
Experience and understanding of sterilization processes and standards
Experience with understanding USP’s and global product standards as required for testing and product quality
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) OUS: 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 communication (written and verbal) High level of integrity, accountability, and ownership Negotiation and strong persuasive abilities, diplomacy, and positive influencing abilities.
Ability to operate in a f ast-paced, highly regulated environment
Strong organizational and prioritization skills

Nice To Haves

Advanced degree (MS, MBA, or equivalent) preferred
Bilingual (English/Spanish) preferred

Responsibilities

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.
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 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 proactive 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 a constant state of inspection readiness.
Act as the primary Quality interface with regulatory authorities.
Lead and manage warning letter, consent decree, and broader regulatory remediation situations, including response strategy, cross-functional remediation governance, health authority commitments, and sustained execution to restore and maintain compliance.
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
Drive Pharma requirements as applicable into design processes.
Lead risk assessments related to product quality and patient safety , including:
Field impact evaluations
Recall decision-making
Health hazard assessments
Ensure timely escalation and management of critical quality issues.