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**Job Function: **
Quality
**Job Sub Function: **
Quality & Compliance Audit
Job Category:
Professional
All Job Posting Locations:
Palm Beach Gardens, Florida, United States of America, Raynham, Massachusetts, United States of America, West Chester, Pennsylvania, United States of America
Job Description:
DePuy Synthes is recruiting for a Manager, Pre‑Clinical & Clinical Compliance, located in Raynham MA or Palm Beach Gardens FL or West Chester PA.
Job Overview
The Manager, Pre‑Clinical & Clinical Compliance is responsible for leading compliance activities supporting pre‑clinical and clinical research programs. This role ensures that study design, execution, documentation, and oversight comply with applicable regulations, quality standards, and internal policies. The position plays a critical role in protecting patient safety, ensuring data integrity, and enabling compliant advancement of products through the development lifecycle by partnering closely with R&D, Clinical, Regulatory Affairs, and Quality teams.
Key Responsibilities
Lead and manage compliance activities for pre‑clinical and clinical programs, ensuring adherence to regulatory and quality requirements.
Provide compliance oversight for study protocols, reports, and 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 internal audits, external audits, and regulatory inspections related to pre‑clinical and clinical compliance.
Monitor compliance risks, trends, and findings; drive corrective and preventive actions as needed.
Ensure consistent application of global and local compliance procedures, controls, and governance.
Drive continuous improvement initiatives to strengthen compliance effectiveness and operational readiness.
Qualifications
Education:
Bachelor’s degree in Life Sciences, Engineering, Regulatory Affairs, Quality, or a related discipline (required).
Advanced degree in a scientific, regulatory, or quality‑related field (preferred).
Experience and Skills:
Required:
Typically 6-8 years of progressive experience in pre‑clinical, clinical, regulatory, or compliance roles within a regulated industry.
Strong working knowledge of compliance requirements applicable to pre‑clinical and clinical research.
Experience supporting audits, inspections, or compliance assessments related to development activities.
Ability to manage complex compliance topics across cross‑functional stakeholder groups.
Preferred:
Experience in medical devices, healthcare, or other highly regulated industries.
Familiarity with global regulatory expectations for pre‑clinical and clinical programs.
Experience working in a global or matrixed organization.
Exposure to regulatory authority interactions related to development compliance.
Quality or Regulatory certifications (e.g., RAC).
Strong analytical, risk‑management, and problem‑solving skills.
Effective written and verbal communication skills.
Other:
Language: English required.
Travel: Limited; occasional domestic travel.
Certifications: Quality or Regulatory certifications preferred but not required.
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.
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.
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.
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Required 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
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:
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 period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits