Manager, Pre‑Clinical & Clinical Compliance

Manager, Pre-Clinical & Clinical Compliance

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.

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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 , internal employees contact AskGS to be directed to your accommodation resource.

Required Skills:

Agile Internal Audit, Analytical Reasoning, Audit and Compliance Trends, Compliance Frameworks, Compliance Management, Compliance Policies, Compliance Risk, Critical Thinking, Process…