Manager, Pre‑Clinical & Clinical Compliance

6149-DePuy Synthes Products Inc. Legal Entity; West Chester (Chester County); On-site; USD 102,000 - 177,000; Full time

Job summary

Johnson & Johnson is seeking a Clinical and Pre‑Clinical QA Compliance Manager to oversee GCP/GLP compliance across multiple U.S. locations, including Raynham, MA and West Chester, PA.

You will partner with R&D, Clinical, Regulatory Affairs, and Quality to ensure audits, lifecycle management, and regulatory adherence for preclinical and clinical programs. The role requires 6–8 years in a GCP Quality function, strong communication skills, and domain expertise with cross‑functional leadership.

Qualifications

• 6–8 years in GCP Clinical Quality or similar function.
• Domestic travel 15–20%.
• Lead Auditor in GCP is advantageous.
• Strong oral and written communication skills.
• Orthopedics medical device experience preferred.
• Domain expert with cross‑functional leadership capabilities.

Responsibilities

• Support GLP pre‑clinical and GCP clinical programs to ensure regulatory and quality compliance.
• Provide clinical compliance oversight for protocols, manuals, reports, and supporting docs.
• Collaborate with R&D, Clinical, Regulatory Affairs and Quality teams for compliant study execution.
• Translate regulations and standards into actionable requirements for study teams.
• Support internal and external GCP/GLP audits and inspections by Health Authorities.
• Assist with quality improvement initiatives and CAPA where needed.
• Contribute to global and local compliance governance and procedures.
• Lead quality assurance activities and risk assessments as assigned.

Skills

Clinical quality

GCP knowledge

Auditing

Regulatory knowledge

Travel readiness

Education

Bachelor's degree

MS or higher degree preferred

Tools

PowerBI

Tableau

ASQ CQA

RAC

PMP

Job description

Company Overview

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. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

Job Summary

DePuy Synthes is recruiting for a Clinical and Pre‑Clinical QA Compliance Manager to be located in Raynham, MA, Palm Beach Gardens, FL, or West Chester, PA.

Job Details

Job Function: Quality

Job Sub Function: Quality & Compliance Audit

Job Category: Professional

Legal Entity Name: 6149-DePuy Synthes Products Inc.

Legal Entity Pay Grade: 30

Primary Job Posting Location: Raynham, Massachusetts, United States of America

Additional Job Posting Locations: Palm Beach Gardens, Florida, West Chester, Pennsylvania, Raritan, New Jersey and Warsaw, Indiana within the United States of America

Key Responsibilities

• Support compliance activities for GLP pre‑clinical and GCP clinical programs, ensuring adherence to regulatory and quality requirements are met according to medical device standards internally and externally
• Assist with providing clinical compliance oversight and reviews as assigned for clinical study protocols, clinical study manuals, reports, and clinical supporting documentation
• Partner with R&D, Clinical, Regulatory Affairs, and Quality teams to support compliant study execution and lifecycle management
• Interpret applicable regulations and standards and translate them into practical compliance requirements for study teams
• Support GCP clinical and GLP clinical quality assurance internal audits, external audits
• May support GCP External Clinical Audits/Inspections from Health Authorities including FDA and/or notified body
• Monitor compliance risks, trends, and findings and elevate as necessary to management
• May be assigned to facilitate quality control activities, including risk assessment, deviation management, and Corrective and Preventive Actions (CAPA) as applicable
• Ensure consistent application of global and local compliance procedures, controls, and governance
• Participate in maintaining the GCP Quality strategies by aligning with global GxP standards, DePuy Synthes Quality Management Systems and DePuy Synthes Quality Policy
• Develop and execute the annual GCP Clinical and GLP Preclinical audit plan in partnership with DePuy Synthes Regulatory Compliance management and present to Clinical Research stakeholders for awareness
• May execute as assigned, clinical audits based on requirements needed irrespective of the audit schedule and based upon clinical risk identification
• May contribute to the standardization, harmonization, and scalability of GCP and GLP Quality Audit processes as applicable
• May be tasked to lead quality improvement initiatives to enhance processes; technical enablement may be required
• May deliver as tasked, input to the Quality Management Review, as applicable

Requirements

• Bachelors required, with MS or other higher degree preferred in Biological or Natural Sciences or equivalent
• 6 to 8 years of progressive experience in a GCP Clinical Quality / GCP Clinical Compliance or Clinical Auditing or similar function with proven leadership experience is required within a medical device regulated industry
• Considered to be a Domain Expert within GCP with the ability to manage complex compliance topics across cross‑functional stakeholder groups
• Travel Expectations: 15 to 20% domestic travel; audits will be conducted internally and externally
• Strong working knowledge of compliance requirements applicable to pre‑clinical research GLP Preclinical experience preferred
• Orthopedics medical device experience is strongly preferred
• Experience as Lead Auditor within GCP is an advantage
• Pro‑active and open-minded, a dedicated team player with excellent oral and written communication skills

Preferred Skills

• Agile Internal Audit
• Analytical Reasoning
• Audit and Compliance Trends
• Compliance Frameworks
• Compliance Management
• Compliance Policies
• Compliance Risk
• Critical Thinking
• Process Improvements
• Quality Auditing
• Quality Control (QC)
• Quality Standards
• Regulatory Compliance
• Risk Management
• Technical Credibility
• Third-Party Auditing

Technical Skills

Development of dashboards, PowerBI and/or Tableau Quality, Project Management, Regulatory certifications (e.g., ASQ CQA, RAC, PMP).

Salary and Benefits

The anticipated base pay range for this position is : $102,000.00 - $177,100.00

Additional Description for Pay Transparency: 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:

Company Updates

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.

Equal Opportunity Employer

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.