Senior Manager Operations Quality - Services Laboratories

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 escalation of 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 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 Benefits Annual Bonus Potential Discretionary LTI Bonus Potential 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. 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. Salary Information $172,000.00 – $275,200.00 USD Annual Location USA – NJ, Branchburg (Primary Work Location) Work Shift: {Work Shift details omitted for brevity} EEO Statement 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. #J-18808-Ljbffr