About
Johnson & Johnson is a global healthcare company operating in Innovative Medicine and MedTech. Johnson & Johnson announced plans to separate its Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process is anticipated to be completed within 18 to 24 months, subject to legal requirements, regulatory approvals, and other customary conditions. Should the candidate accept this position, it is anticipated that, following conclusion of the transaction, they would become an employee of DePuy Synthes, with employment governed by DePuy Synthes' employment processes, programs, policies, and benefit plans.
Job Function: Legal & Compliance
Job Sub Function: Law Business Partners
Job Category: Professional
Location: Raynham, Massachusetts, United States of America
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.
Experience and Skills — Preferred
•Experience supporting regulatory inspections, audits, or health authority inquiries.
•Background in orthopedic or implantable medical device manufacturing.
•Experience using electronic quality management systems (eQMS).
•Experience leading global or multi-site investigation teams.
•Training or certification in root cause analysis or quality methodologies (e.g., Six Sigma).
•Strong analytical, communication, and decision-making skills.
Other
•Language: English proficiency required.
•Travel: Up to 15–20% domestic and/or international travel.
•Certifications (preferred): ASQ, Six Sigma, or equivalent quality certifications.
Preferred Skills: Analytical Reasoning, Business Agility, Commercial Laws, Compliance Management, Corporate Governance, Dispute Resolution, Lawyering, Legal Services, Litigation, Negotiation, Organizing, Process Improvements, Representing, Strategic Thinking, Tactical Thinking, Technical Credibility
Compensation and Benefits
The anticipated base pay range for this position is $122,000.00 - $212,750.00.
Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company's long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
•Vacation – 120 hours per calendar year
•Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado – 48 hours per calendar year; for employees who reside in the State of Washington – 56 hours per calendar year
•Holiday pay, including Floating Holidays – 13 days per calendar year
•Work, Personal and Family Time - up to 40 hours per calendar year
•Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
•Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year
•Caregiver Leave – 80 hours in a 52-week rolling period
•Volunteer Leave – 32 hours per calendar year
•Military Spouse Time-Off – 80 hours per calendar year
This job posting is anticipated to close on June 1, 2026. The Company may extend this time-period, in which case the posting will remain available to accept additional applications.
