New · posted Nov 10
Becton Dickinson · Medical Devices
Associate Director - Quality - Laboratory Services
- Branchburg, NJ
- On-site
- Full-time
- Director
The role
The Associate Director, Quality – Laboratory Services provides strategic Quality leadership and oversight for three Laboratory Services sites across the U.S. and France. As a member of the Laboratory Services leadership team, this role leads the laboratory Quality organization, drives an effective and harmonized Quality Management System (QMS), and provides independent oversight of compliance, customer, and business risks.
This position partners with business and functional leaders to strengthen regulatory compliance, Quality performance, customer trust, operational excellence, and laboratory transformation.
What you need
Minimum Qualifications
- Master’s degree or equivalent in Life Sciences, Pharmacy, Chemistry, Microbiology, or a related scientific field.
- At least 10 years of progressive Quality experience within the pharmaceutical, medical device, or life sciences industry, including 5 years in a leadership or management role, preferably supporting laboratory operations or multi-site activities.
- Strong knowledge of cGMP, ISO/IEC 17025, ISO 13485, FDA requirements, and applicable European medical device regulations.
- Demonstrated experience leading and hosting regulatory inspections and customer audits, including FDA and other Health Authority interactions, inspection readiness, and remediation activities.
- Proven experience leading and developing high-performing teams through change and organizational transformation.
- Demonstrated experience providing Quality leadership across multiple sites, establishing governance, driving standardization, and ensuring consistent implementation of Quality System requirements.
- Strong business acumen and ability to influence senior and cross-functional stakeholders while balancing compliance, risk, operational performance, and business priorities.
- Strong analytical, risk-based decision-making, problem-solving, communication, and organizational skills.
- Experience with LIMS, data integrity principles, and computerized system requirements.
- Excellent written and verbal communication skills in English.
Required Skills
Optional Skills
Preferred Qualificationnice to have
- Proficiency in French.
At BD, we are committed to supporting our associates’ well-being, development, and success through a performance-based culture. For this position, BD offers a competitive compensation package along with the following benefits specific to this role:
- Annual Bonus
- Potential Discretionary LTI Bonus
- Potential reimbursement of phone use
What you'll do
- Quality Strategy & Leadership: Define and execute the Quality strategy, priorities, and objectives for the laboratory network, aligned with Pharmaceutical Systems Quality and business priorities.
- Quality Governance: Establish effective governance across three laboratories, ensuring appropriate Quality oversight, accountability, and timely risk escalation.
- QMS Leadership: Lead the effectiveness and continuous improvement of the laboratory QMS, including simplification, standardization, and cross-site harmonization.
- Compliance & Inspection Readiness: Maintain readiness for regulatory inspections, accreditation assessments, and customer audits and oversee significant remediation activities.
- Quality Risk & Performance: Provide senior oversight of significant nonconformances, investigations, CAPAs, changes, and systemic Quality risks. Use Quality metrics and trends to inform priorities and decisions.
- Customer Quality: Provide leadership for critical customer Quality matters and ensure consistent management of customer requirements and Quality Agreements.
- Transformation: Lead the Quality aspects of laboratory transformation, including digitalization, LIMS implementation, data integrity, and Quality process improvements.
Pay
$183,800 – $294,100 a year
Employer providedSalary Range Information
$183,800.00 - $294,100.00 USD Annual
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.
Health & Well-being: Medical, dental, vision, health savings and flexible spending accounts, life and disability insurance, wellness resources, mental health support, and disease management programs.
Retirement & Financial Well-being: 401(k), deferred compensation programs, financial counseling, DailyPay, and educational savings resources.
Work-Life Balance & Family Support: Paid time off, company holidays, educational assistance, parental leave, adoption assistance, backup care, caregiving support, employee assistance programs, commuter benefits, pet insurance, legal services, and associate discount programs.
Leave Programs: Bereavement, military, personal, family and medical leave, and jury duty leave.
Additional details regarding benefits and well-being programs can be found in Our Commitment to You.
Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed
Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.
Where you'll work
Branchburg, NJOn-siteOpen in Maps (opens in a new tab)
More jobs in Branchburg, NJWorking conditions
At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs.
Primary Work Location
USA NJ Branchburg
From the posting
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™ 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.
Equal opportunity, accessibility and legal noticesBecton Dickinson's statements, word for word
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.
Job intelligence
The context around this role
Live data · November 10, 2026
Salary intelligence
How the pay compares
This role's midpoint is 12% above the US median for Quality Systems & Document Control roles at this level.
This roleEmployer provided
Director roles in the US11 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $183,800 | — | $294,100 |
| All US (middle half) | $189,500 | $213,500 | $231,000 |
This role: Becton Dickinson's own published range. Comparisons: the base pay employers published on open Quality Systems & Document Control roles at the same level on Regulatory Jobs, November 10, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Systems & Document Control
The general path across 91 open Quality Systems & Document Control roles on Regulatory Jobs, with the titles they carry most. Not BD's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 25 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership11
- Lab testing and methods9
- GMP and compliance6
- Quality systems and risk6
- Data and digital systems2
- Investigations and CAPA1
- Regulatory submissions1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Systems & Document Control work in medical devices, led by the four this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices, aligned with ISO 13485Named in the posting
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devicesNamed in the posting
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and AnswersNamed in the posting
- ISOISO/IEC 17025(official source, opens in a new tab)Competence of testing and calibration laboratoriesNamed in the posting
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- ISOISO 14971(official source, opens in a new tab)Application of risk management to medical devices
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- EUEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation: CE marking, technical documentation, vigilance
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- ISPEISPE GAMP 5(official source, opens in a new tab)A risk-based approach to compliant GxP computerized systems
- FDA21 CFR Part 56(official source, opens in a new tab)Institutional review boards for FDA-regulated clinical investigations
- FDAFDA Computer Software Assurance(official source, opens in a new tab)Risk-based assurance for production and quality system software
- FDAMDSAP(official source, opens in a new tab)The Medical Device Single Audit Program shared by five regulators
- FDA21 CFR Part 803(official source, opens in a new tab)Medical device reporting of deaths, serious injuries and malfunctions
- FDA21 CFR Part 806(official source, opens in a new tab)Reports of medical device corrections and removals
- FDA21 CFR Part 830 (UDI)(official source, opens in a new tab)Unique device identification and the GUDID database
Company hiring pulse
BD on Regulatory Jobs
- 102
- Open roles
- 102
- Distinct roles
- 23
- Locations
By discipline
- Quality77 75%
- Regulatory18 17%
- Clinical8 8%
By level
- Senior & Principal48 47%
- Associate & Specialist34 33%
- Manager17 17%
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