Senior Manager Operations Quality - Services Laboratories

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.

Requirements

• 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
• Other Well-being Resources
• 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 servic

Benefits

Additional Information

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

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