Join BD as an Associate Director - Quality - Laboratory Services based in Branchburg, USA. In this leadership role, you will provide strategic quality oversight for three laboratory sites across the U.S. and France, driving regulatory compliance, QMS harmonization, and laboratory transformation.
Requirements
Master’s degree in Life Sciences, Pharmacy, Chemistry, Microbiology, or related scientific field.
At least 10 years of progressive Quality experience in the pharmaceutical, medical device, or life sciences industry.
Minimum of 5 years in a leadership or management role supporting laboratory or multi-site activities.
Strong knowledge of cGMP, ISO/IEC 17025, ISO 13485, and FDA regulations.
Preferred: Proficiency in French.
Skills & Responsibilities
Quality Leadership: Define and execute quality strategy, priorities, and objectives across the laboratory network to ensure compliance and risk mitigation.
QMS Management: Lead the effectiveness, continuous improvement, simplification, and cross-site harmonization of the laboratory Quality Management System.
Audit & Inspection Readiness: Maintain readiness for regulatory inspections, accreditation assessments, and customer audits while overseeing remediation activities.
Data Integrity & LIMS: Guide quality aspects of laboratory transformation, including digitalization, LIMS implementation, and computerized system compliance.
Potential transition routes: People from Quality Assurance Manager or Regulatory Affairs Director roles may bring multi-site leadership experience and compliance expertise, alongside meeting the mandatory industry background requirements.
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
Job Summary
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.
Key Responsibilities
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.
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
Associate Director - Quality - Laboratory Services
Branchburg, New Jersey
On-site
$183,800 - $294,100 / year
-
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.
Preferred Qualification
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
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.
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
.
Primary Work Location
USA NJ Branchburg
Additional Locations
Work Shift
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.
Benefits may include:
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.
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.
