Becton, Dickinson and Company

Sr. Director, Operations Quality Management

Becton, Dickinson and Company • $150K — $180K *
El Paso, TX 79936In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
3 weeks ago
Job Overview by Ladders

Qualifications

  • Bachelor's degree in Science, Engineering, or related discipline; advanced degree preferred
  • 10+ years of experience in the regulated pharmaceutical industry
  • 5+ years in leadership roles within Quality
  • Experience managing regulatory inspections and responses
  • Strong knowledge of global regulatory requirements and GMP systems
  • Oversight of chemical and microbiological activities in an operational role
  • Experience with sterilization processes and standards

Responsibilities

  • Define and execute the site Quality Strategy aligning with global objectives
  • Influence risk-based decision-making as a member of the site leadership team
  • Foster a strong quality culture emphasizing accountability and transparency
  • Lead and develop the Quality organization for capability and succession planning
  • Manage inspection readiness programs ensuring compliance at the site
  • Collaborate with R&D to facilitate technology transfers for new products
  • Lead regulatory inspections and respond to health authority observations

Benefits

  • Opportunity to play a critical role in product quality and regulatory compliance
  • Ability to influence and lead cross-functional teams at a strategic level
  • Engagement in continuous improvement and quality culture development
  • Chance to work in a fast-paced, highly regulated environment
  • Support for professional development and career advancement opportunities
Full Job Description
Job Description

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 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.


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.
  • 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.


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
    • Drive Pharma requirements as applicable into design processes.
Risk Management & Product Impact Assessment
  • 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.


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 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


Knowledge and Skills:

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)
  • 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.
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

Primary Work Location
USA TX - El Paso - Northwestern Dr.

Additional Locations

Work Shift

About Becton, Dickinson and Company

BD is a global technology company that provides diagnostics and technologies for frontliners. Through their solutions and services, they assist scientists in detecting diseases and advanced researchers' on developing diagnoses and therapeutics. BD was established in 1897 by Farleigh Dickinson and Maxwell Becton in East Rutherford, New Jersey.

Becton, Dickinson and Company Careers

Join the innovative world of Becton, Dickinson and Company (BD), a global medical technology company that is actively seeking driven, dedicated professionals to join our team. At BD, we are committed to advancing the world of health by improving medical discovery, diagnostics, and the delivery of care. This commitment provides the foundation for a workplace where you can engage in meaningful work and where job opportunities abound.

Work You’ll Do

At BD, you will be part of a culture that values diversity, leadership, and innovation. Our team members are empowered to lead and inspire from day one. Join us and contribute to our mission of advancing the world of health through your professional skills and personal passion.

Transform Your Career

BD offers a unique position in the marketplace that combines industry expertise, leadership in medical innovation, and a collaborative culture to help you grow your career. Whether you are looking for an entry-level position or a more senior role, we provide the tools and support for your professional growth through comprehensive training and development programs.

Innovative Work Environment

Our team at BD is composed of more than 65,000 associates across the globe. These dedicated professionals work at the intersection of technology and healthcare, where they drive innovation and ensure that we stay ahead in a rapidly evolving industry. By joining BD, you will work alongside some of the brightest minds in the industry.

Internship and Employment Opportunities

Start your career with BD through our internship programs or dive straight into a full-time position. We offer a range of opportunities that allow you to explore different areas of our business and find a path that aligns with your career goals. Our hiring process is designed to be transparent and engaging, ensuring that all candidates—whether submitting a resume for an internship or a senior position—feel valued and informed.

Benefits and Culture

BD is proud to offer competitive benefits that support the health, well-being, and financial security of our employees and their families. From comprehensive health insurance to employee wellness programs and flexible working arrangements, we prioritize the well-being of our team members. Our inclusive culture encourages networking, continuous learning, and the sharing of ideas in a diverse and welcoming environment.

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Explore the job opportunities at BD and discover how your expertise can help shape the future of healthcare. Search open positions that match your skills and interests. We look for passionate, curious, creative, and solution-driven team players.

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At Becton, Dickinson and Company, we are more than just a company; we are a community that is dedicated to making a difference in the lives of people all around the world.
Learn more about Becton, Dickinson and Company
Size
75,000 employees
Market Cap
$72 billion
Industry
Healthcare
Net Income
$1.6 billion
Founded
1897
5 Year Trend
+9.3%
Revenue
$18.2 billion
NASDAQ
BDX
* Ladders Estimates

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