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 Manager, Quality - Services Laboratories leads the Quality Management System (QMS) for ZebraSci's U.S. laboratory operations, ensuring regulatory compliance and driving continuous improvement.
This role provides Quality leadership to maintain compliance with FDA regulations, ISO standards, and accreditation requirements while supporting efficient lab operations and alignment with BD Pharmaceutical Systems.
As the primary site Quality partner, this position collaborates closely with Laboratory Operations and site leadership to address risks, drive quality performance, and escalate key trends and strategic issues
Key Responsibilities
Quality Systems & Compliance
Lead implementation and continuous improvement of the ZebraSci QMS across U.S. laboratories, ensuring alignment with BD Pharmaceutical Systems requirements.
Monitor QMS performance, quality metrics, and system health; drive corrective actions to address gaps.
Maintain compliance with ISO/IEC 17025, ISO 13485, and applicable laboratory quality standards.
Regulatory & Inspection Leadership
Serve as Business Process Owner for audit and inspection management.
Act as primary Quality contact for FDA inspections, ISO audits, and customer audits.
Lead end-to-end inspection readiness, including preparation, on-site execution, and post-inspection responses (CAPAs).
Drive a proactive, inspection-ready culture and oversee audit observations, remediation, and effectiveness checks.
CAPA, Deviations & Risk Management
Own site-level Quality event processes (deviations, nonconformances, CAPA).
Ensure robust root cause analysis, implementation of corrective actions, and effectiveness verification.
Identify and escalate compliance risks using a risk-based approach.
Leadership & Cross-Functional Partnership
Lead, coach, and develop Quality team members to build capability and performance.
Partner with laboratory and site leadership to enable compliant, efficient operations.
Influence cross-functional teams to embed Quality by Design and right-first-time execution.
Continuous Improvement & Governance
Lead Management Review inputs and analyze Quality data trends to drive continuous improvement.
Support change management related to systems, processes, and regulatory requirements.
Qualifications
Required
Bachelor's degree in Life Sciences, Engineering, or related field
8+ years of Quality experience in regulated environments (pharma, medical device, labs, or combination products)
Hands-on experience supporting FDA inspections and ISO audits
Working knowledge of:
21 CFR Parts 4, 210, 211, 820
ISO 13485 and ISO/IEC 17025
Preferred
Experience in contract testing labs or service organizations
Experience with functional or mechanical testing
Prior leadership experience (people or functional)
Background in global or matrixed organizations
Core Competencies
Regulatory and compliance leadership
Risk-based decision-making
People leadership and influencing skills
Continuous improvement mindset
Strong communication skills
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
Health and Well-being Benefits
Medical coverage, Health Savings Accounts, Flexible Spending Accounts, Dental coverage, Vision coverage, Hospital Care Insurance, Critical Illness Insurance, Accidental Injury Insurance, Life and AD&D insurance, Short-term disability coverage, Long-term disability insurance, Long-term care with life insurance.
Other Well-being Resources
Anxiety management program, wellness incentives, sleep improvement program, diabetes management program, virtual physical therapy, emotional/mental health support programs, weight management programs, gastrointestinal health program, substance use management program, musculoskeletal surgery, cancer treatment, and bariatric surgery benefit.
Retirement and Financial Well-being
BD 401(k) Plan, BD Deferred Compensation and Restoration Plan, 529 College Savings Plan, financial counseling, Baxter Credit Union (BCU), Daily Pay, college financial aid and application guidance.
Life Balance Programs
Paid time off (PTO), including all required State leaves, educational assistance/tuition reimbursement, MetLife Legal Plan, group auto and home insurance, pet insurance, commuter benefits, discounts on products and services, Academic Achievement Scholarship, Service Recognition Awards, employer matching donation, workplace accommodations.
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
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. You can learn more on our career site under "Our Commitment to You (https://jobs.bd.com/en/your-career-at-BD) ."
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.
Salary Range Information
$172,000.00 - $275,200.00 USD Annual
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status.
