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Director, Technical Quality – Compliance
Johnson & Johnson. Provide strategic leadership for Medical Device Regulatory activities .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Medical Device Regulatory activities, ensuring compliance with GxP regulations and global cGMP standards while driving quality system transformation. Proficient in managing regulatory data integrity and governance throughout the product lifecycle.
Highest-signal resume keywords
GxP Computerized Systems Validation (CSV)Regulatory SubmissionsQuality System TransformationGlobal cGMP RegulationsTechnical Quality & Compliance Expertise
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
GxP RegulationsData IntegritySDLC GovernanceValidation Lifecycle ManagementElectronic Records/SignaturesAudit TrailsInspection ReadinessQuality Management SystemsAutomationDigital Transformation
Tools & Technologies
Electronic Quality Management SystemsTraining Systems
Certifications & Qualifications
Certified Software Quality Engineer (CSQE)Certified Quality Engineer (SQE)Certified Quality Auditor (SQA)Project Management Professional (PMP)
Industry Keywords
Medical DevicesPharmaceuticalBiotechRegulated IndustriesGlobal Regulatory ReadinessQuality StandardsMatrixed Organizations
Tech Stack
Tools & technologiesPMPSDLC
About the role
Key responsibilities & impact- Provide strategic leadership for Medical Device Regulatory activities
- Ensure integrity, governance, and effective use of regulatory data across the product lifecycle
- Support compliance, regulatory submissions, and informed decision-making
- Strengthen regulatory capabilities and enable digital transformation
- Support global regulatory readiness within DePuy Synthes
- Ensure J&J quality standards and global regulatory requirements are met
- Ensure early quality involvement in design and development activities
- Build quality into work products and controls into applications and solutions
- Use automation whenever feasible
- Provide Technical Quality & Compliance expertise and guidance to project teams
Requirements
What you’ll need- Bachelor’s degree in Computer Science, Information Systems, Business Administration or another related field required
- 10–12 years of experience leading GxP computerized systems validation (CSV) within pharmaceutical, medical device, biotech, or other regulated industries
- Deep understanding of GxP regulations and compliance requirements, including data integrity, SDLC governance, validation lifecycle management, electronic records/signatures, audit trails, and inspection readiness
- Thorough knowledge of global cGMP regulations and computerized systems requirements
- English required
- Moderate international travel
- Experience in medical devices, healthcare, or other highly regulated industries preferred
- Experience working in global, matrixed organizations preferred
- Familiarity with electronic quality management and training systems preferred
- Demonstrated success driving quality system transformation or harmonization initiatives preferred
- Quality or Regulatory certifications preferred but not required
- Additional European languages preferred
- Certified Software Quality Engineer (CSQE), Certified Quality Engineer (SQE), Certified Quality Auditor (SQA), Project Management Professional (PMP) or similar preferred
Benefits
Comp & perks- Inclusive work environment
- Interview process accommodations for applicants with disabilities
- Employee wellness, career, and life support resources