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Associate Director Quality System Jobs (NOW HIRING)

Replimune

Director, Quality Systems

Framingham, MA · On-site

$191K - $247K/yr

The Director, Quality Systems has the opportunity to create influential and collaborative ... Drive quality system initiatives and improvement activities while partnering across functions and ...

Replimune-2

Director, Quality Systems

Framingham, MA · On-site

$191K - $247K/yr

The Director, Quality Systems has the opportunity to create influential and collaborative ... Drive quality system initiatives and improvement activities while partnering across functions and ...

Talanto

Associate Director, Quality Assurance & Governance 12,333 - 17,000 $ About This Role The Associate ... Support the development, maintenance, and continuous improvement of the Quality Management System ...

Baxter

Associate Director, Quality

Hayward, CA · On-site

$160K - $220K/yr

Direct large-scale programs and departmental initiatives in support of division-wide and company ... Develop, implement, and maintain quality systems, including Management Review, CAPA, Design ...

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As of Sep 11, 2026, the average hourly pay for associate director quality system in the United States is $26.93, according to ZipRecruiter salary data. Most workers in this role earn between $18.27 and $31.49 per hour, depending on experience, location, and employer.

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Associate Director Quality Assurance

El Paso, TX • On-site

Becton, Dickinson and Company
Medical Equipment and Supplies Manufacturing • 10K+ employees
Learn more about Becton, Dickinson and Companyexternal

Full-time

This job post has expired today. Applications are no longer accepted.

BD rating

7.3

Company rating: 7.3 out of 10

Based on 143 frontline employees who took The Breakroom Quiz

Job description

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
The Associate Director, Quality Assurance provides strategic leadership and oversight of the site Manufacturing Operations to ensure compliance with the applicable regulations such as: FDA regulations (21 CFR Parts 210, 211, and 820 as applicable), EU GMP, and ISO 13485 standards.
This role is accountable for Quality oversight across the manufacturing process of formulation, filling, triton and Cascade Water Sterilization process (CWS). The position supports and oversight contamination control strategies, risk-based decision-making, and sustainable compliance culture, while enabling operational excellence and supply continuity.
The Associate Director acts as a key member of the site quality leadership team, driving quality strategy, regulatory readiness, and continuous improvement initiatives aligned with global and site objectives.
Works collaboratively with Manufacturing, Supply Chain, EHS, Engineering, and other cross-functional teams.
Job Responsibilities:
Operations Quality Oversight
  • Ensure adherence to cGMP requirements (21 CFR 210/211, 820 as applicable), EU GMP, and ISO standards.
  • Provide independent Quality oversight of manufacturing operations, including:
    • In-process controls and testing
    • Batch record review and approval
    • Ensure timely disposition decisions based on sound risk assessment and regulatory requirements.
    • Drive increased Quality presence on the shop floor to ensure real-time compliance and issue resolution.
    • Ensure production and process controls are aligned with validated states and lifecycle requirements.
  • Ensure all investigations, CAPA, deviations, change control, complaints, in your area of responsibility are effectively implemented, sustainable, and inspection-ready.
  • Maintain proactive and effective communication with R&D, Design, Regulatory Affairs, and Pharma stakeholders.

Compliance, Risk Management & Continuous Improvement
  • Drive risk-based decision-making using quality risk management principles.
  • Analyze trends across investigations, complaints, and process performance to identify systemic issues and drive improvements.
  • Leads the development and documentation of structured, data-driven analyses to support root cause identification, decision-making, and continuous improvement initiatives.
  • Serves as the QA Subject Matter Expert (SME) during internal and external regulatory inspections, ensuring accurate representation of quality systems and compliance posture.
  • Ensure effectiveness of CAPAs through robust verification of effectiveness (VoE).
  • Defines and anticipates data requirements, including non-standard datasets, and ensures the collection of robust, high-quality data to support the evaluation of complex issues and operational challenges.
  • Leverages hypothesis-driven analysis and deep understanding of cause-and-effect relationships to evaluate complex processes, identify trends, and interpret data patterns.
  • Serves as a Subject Matter Expert (SME) in leading and documenting comprehensive, data-driven situational analyses to support strategic decision-making, regulatory compliance, and continuous improvement initiatives.

Leadership & Talent Development
  • Lead, coach, and develop a high-performing QA organization, ensuring appropriate capability across operations and quality systems.
  • Establish clear accountability, drive ownership, urgency, and execution discipline across the team.
  • Develop succession plans and ensure organizational readiness to sustain compliance.
  • Foster a culture of quality, transparency, and continuous improvement.

Business & Strategic Contribution
  • Act as a key contributor to the quality site leadership team, aligning quality strategy with business objectives.
  • Manage departmental budget, resources, and priorities to ensure effective deployment aligned with business needs and compliance risks.

Education and Experience:
  • Bachelor's degree in Chemical Engineering or Science. (Master's Degree preferred).
  • Minimum 10+ years of experience in Quality within pharmaceutical manufacturing experience.
  • Minimum 5+ years in leadership roles with direct people management responsibility.
  • Strong experience with FDA inspections and regulatory interactions (e.g., 483s, Warning Letters).

Knowledge and Skills:
Experience in interface with Domestic and Foreign government agencies
• Experience with SAP preferred
• Experience in Lean/Six Sigma preferred
• Computer proficiency in Microsoft Office (Word, Excel, Power Point, Project, and Outlook).
Pharmaceutical experience is a must.
Physical Demands:
• Must be able to lift, push/pull, and carry up to 25 pounds
• Must be able to wear appropriate personal protective equipment as required
• Position requires sitting or standing for long hours
• Use of hands and fingers to manipulate office and calibration equipment is required
Work Environment:
Manufacturing
Why Join Us?
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you'll discover a culture in which you can learn, grow and thrive.
We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.
To learn more about BD visit https://bd.com/careers.
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, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.
Required Skills
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Primary Work Location
USA TX - El Paso - Northwestern Dr.
Additional Locations
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About BD

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BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.

Industry

Medical equipment and supplies manufacturing and manufacturing

Company size

10,000+ Employees

Headquarters location

Franklin Lakes, NJ, US

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