Sr. Manager, Investigations

Johnson & Johnson Raynham, Massachusetts, United States of America Updated 14 October 2026
PharmaMedTechRegulatory AffairsQuality Assuranceemafdacroraveinformaws

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Legal & Compliance Job Sub Function: Law Business Partners Job Category: Professional All Job Posting Locations: Raynham, Massachusetts, United States of America Job Description: Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes. Job Overview The Sr. Manager, Investigations provides strategic and operational leadership for investigation activities related to quality events, compliance issues, and regulatory requirements impacting DePuy Synthes products and operations. This role is accountable for ensuring investigations are thorough, timely , compliant, and consistently executed across the organization. The position partners closely with Quality, Regulatory Affairs, Manufacturing, R&D, Legal, and Compliance to identify root causes, define corrective and preventive actions, and reduce risk to patients, customers, and the business. This is a highly visible role with direct impact on product quality, regulatory compliance, and continuous improvement. Key Responsibilities Lead and oversee investigation activities related to quality events, nonconformances, complaints, deviations, and compliance issues. Ensure investigations are conducted in accordance with internal procedures, regulatory requirements, and global quality system standards. Drive consistent root cause analysis and corrective and preventive action (CAPA) development and effectiveness. Partner cross‑functionally with Manufacturing, Quality, Regulatory Affairs, R&D, and Legal to assess risk and resolve complex issues. Establish and maintain investigation governance, metrics, and reporting to monitor performance, trends, and compliance. Support regulatory inspections, audits, and health authority interactions by providing investigation expertise and documentation. Identify systemic issues and lead continuous improvement initiatives to reduce recurrence and improve investigation quality. Lead, coach, and develop investigation teams or subject‑matter experts, fostering accountability and high performance. Embed Johnson & Johnson’s Credo and Leadership Imperatives into decision‑making, people leadership, and issue resolution. Qualifications Education Bachelor’s degree required , preferably in Engineering, Life Sciences, Quality, or a related technical field. Advanced degree ( Master’s or PhD) preferred. Experience and Skills Required Typically requires 8–10 years of progressive experience in investigations, quality, compliance, or related roles within a regulated industry. Demonstrated expertise in investigation methodologies, root cause analysis, and CAPA processes. Strong knowledge of medical device regulations and quality system requirements (e.g., FDA, ISO). Proven people‑leadership experience, including coaching, performance management, and team development. Ability to lead complex issue resolution and influence senior stakeholders in a matrixed environment. Preferred Experience supporting regulatory inspections, audits, or health authority inquiries. Background in orthopedic or implantable medical

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