Manager, PreClinical & Clinical Compliance

DePuy Synthes is recruiting for a Manager PreClinical & Clinical Compliancelocatedin Raynham MA or Palm Beach Gardens FL or West Chester PA.

Job Overview

The Manager PreClinical & ClinicalComplianceis responsible forleading compliance activities supporting preclinical and clinical research programs. This role ensures that study design execution documentation and oversightcomply withapplicable 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 thedevelopmentlifecycle by partnering closely with R&D Clinical Regulatory Affairs and Quality teams.

Key Responsibilities

• Lead and manage compliance activities for preclinical 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 preclinical 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 strengthencomplianceeffectiveness and operational readiness.

Qualifications

Education:

• Bachelors degree in Life Sciences Engineering Regulatory Affairs Quality ora relateddiscipline (required).

• Advanced degree in a scientific regulatory or qualityrelated field (preferred).

Experience and Skills:

Required:

• Typically6-8 years of progressive experience in preclinical clinical regulatory or compliance roles within a regulated industry.

• Strong working knowledge of compliance requirements applicable to preclinical and clinical research.

• Experience supporting audits inspections or compliance assessments related to development activities.

• Ability to manage complex compliance topics across crossfunctional stakeholder groups.

Preferred:

• Experience in medical devices healthcare or other highly regulated industries.

• Familiarity with global regulatory expectations for preclinical and clinical programs.

• Experience working in a global or matrixed organization.

• Exposure to regulatoryauthorityinteractions related to development compliance.

• Quality or Regulatory certifications (e.g. RAC).

• Strong analytical riskmanagement and problemsolving skills.

• Effective written and verbal communication skills.

Other:

• Language: English.

• Travel: Limited; occasional domestic travel.

• Certifications: Quality or Regulatory certifications preferred but not.

For more information on how we support the whole health of our employees throughout their wellnesscareerand life journey please visit.

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 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.

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