Clinical & Preclinical Compliance Lead

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

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.