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.
The Associate Director, Quality Control 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.
The Associate Director, Microbiology, Incoming & Chemical Laboratory is responsible for providing strategic leadership, technical oversight, and regulatory compliance for microbiology, incoming materials testing, and chemical laboratory operations. This role ensures alignment with GMP, FDA, EU Annex 1, and global quality requirements while driving a robust contamination control strategy (CCS), data integrity, and laboratory excellence.
The position oversees all testing activities related to microbiological control, raw material release, and chemical analysis, ensuring that systems, processes, and personnel support timely and compliant product disposition and regulatory readiness.
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:
Laboratory Oversight & Operations
Provide leadership and oversight for:
Microbiology Laboratory (environmental monitoring, sterility, bioburden, water testing)
Incoming Materials Inspection and Testing
Chemical / Analytical Laboratory
Ensure all laboratory testing is executed in compliance with GMP requirements (21 CFR Parts 210/211, ISO 13485, EU Annex 1).
Ensure laboratories are adequately resourced, including staffing, equipment, and capabilities.
Drive standardization, harmonization, and continuous improvement of laboratory practices across the site.
Microbiology & Contamination Control
Act as the site SME for microbiology and contamination control.
Ensure effective implementation and maintenance of the Contamination Control Strategy (CCS) in alignment with EU Annex 1.
Provide oversight of:
Environmental Monitoring (EM) program
Water systems (PW/WFI)
Cleanroom qualification and control
Microbiological trending and investigations
Cleaning
Ensure robust identification, trending, and mitigation of microbiological risks.
Incoming Material Control
Ensure effective controls for incoming materials, including:
Sampling plans and testing strategies
Supplier qualification alignment with testing requirements
Risk-based material release processes
Drive improvements in incoming testing efficiency while maintaining compliance.
Ensure alignment between supplier quality programs and laboratory testing requirements.
Chemical / Analytical Laboratory Management
Quality Oversight & Compliance
Ensure all laboratory activities operate within the Quality System, including:
Serve as SME during:
Internal and external audits (FDA, EU, notified bodies)
Regulatory inspections and responses (e.g., 483s, Warning Letters)
Lead or support investigations with microbiological or analytical impact, ensuring scientific rigor and timely closure.
Data Integrity & Digital Systems
Ensure ALCOA+ principles are embedded across laboratory systems.
Oversee laboratory computerized systems (e.g., LIMS, analytical software) ensuring compliance with:
Support CSV lifecycle activities as applicable.
Leadership & Talent Development
Build and develop a high-performing laboratory organization.
Provide coaching and technical mentorship to microbiology and analytical teams.
Foster a culture of:
Ensure appropriate technical expertise (e.g., microbiology SME presence) is in place.
Continuous Improvement & Strategy
Education and Experience:
Bachelor’s degree in Microbiology, Chemistry, Biology, or related scientific discipline (Master’s or PhD preferred).
10+ years of experience in Quality/Laboratory functions within pharmaceutical manufacturing.
Minimum 5 years in leadership roles overseeing laboratory operations.
Strong expertise in:
Microbiology (environmental monitoring, water systems, sterility assurance)
Analytical chemistry and laboratory controls
Incoming material quality systems
Proven experience supporting FDA inspections and regulatory responses.
Knowledge and Skills:
Technical Competencies
Leadership Competencies
Strategic mindset with strong execution capability
Ability to drive accountability and ownership across teams
Strong decision-making based on risk and compliance considerations
Ability to influence across all levels of the organization
Behavioral Competencies
Results-driven with strong sense of urgency
High level of organization and prioritization
Strong collaboration and communication skills
Ability to manage complexity and competing priorities
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
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 visithttps://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
Optional Skills
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USA TX - El Paso - Northwestern Dr.
