Associate Director - Quality - Laboratory Services
Becton Dickinson
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.
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-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.
Requirements
- 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
- 5 years in a leadership or management role
- 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
- Proven experience leading and developing high-performing teams through change and organizational transformation
- Demonstrated experience providing Quality leadership across multiple sites
- Strong business acumen and ability to influence senior and cross-functional stakeholders
- 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
- Proficiency in French (preferred)
Benefits
- Medical, Dental & Vision
- Health Savings Account
- Flexible Spending Accounts
- Life & Disability Insurance
- Wellness Resources
- Mental Health Support
- 401(k)
- Deferred Compensation
- Financial Counseling
- Educational Assistance
- Paid Time Off
- Company Holidays
- Parental Leave
- Adoption Assistance
- Backup Care
- Caregiving Support
- Employee Assistance Programs
- Commuter Benefits
- Pet Insurance
- Legal Services
- Annual Bonus Potential
- Discretionary LTI Bonus Potential
Company overview
Becton, Dickinson and Company (BD) is a leading American multinational medical technology company founded in 1897 and headquartered in Franklin Lakes, New Jersey. As one of the largest global medical technology companies, BD specializes in manufacturing and selling medical devices, instrument systems, and reagents while also providing consulting and analytics services. The company operates through three main segments: BD Medical (focusing on medication delivery and management), BD Life Sciences (specializing in diagnostics and biosciences), and BD Interventional (concentrating on surgical and critical care interventions). With over 72,000 employees worldwide, BD has established a significant presence in virtually every country and serves healthcare providers, hospitals, clinics, pharmaceutical companies, and research institutions. The company is publicly traded on the New York Stock Exchange (NYSE: BDX) and is a component of the S&P 500 index. BD has a long history of innovation, including developing the first insulin injection device in 1924, the first sterile disposable medical device in 1952, and pioneering safety-engineered syringes. The company continues to advance healthcare through its commitment to improving medical discovery, diagnostics, and care delivery while addressing global health challenges.