Director, Technical Quality & Compliance

About the Role

The Director, Technical Quality & Compliance, provides strategic leadership for Medical Device Regulatory activities. This role ensures the integrity, governance, and effective use of regulatory data to support compliance, regulatory submissions, and informed decision-making across the product lifecycle. The position plays a critical role in strengthening regulatory capabilities, enabling digital transformation, and supporting global regulatory readiness within DePuy Synthes.

Responsibilities

• Ensure all J&J quality standards and global regulatory requirements are met.
• Ensure early involvement of quality in design and development activities, building quality into the work product, and incorporating controls within applications/solutions.
• Promote the use of automation whenever feasible.
• Provide TQ&C expertise and guidance to project teams.

Qualifications

• Bachelor’s degree in Computer Science, Information Systems, Business Administration, or a related field (Advanced degree preferred).

Required Experience and Skills

• 10-12 years of experience leading GxP computerized systems validation (CSV) in 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 proficiency; additional European languages preferred.
• Moderate international travel required.

Preferred Experience and Skills

• Experience in medical devices, healthcare, or other highly regulated industries.
• Experience working in global, matrixed organizations.
• Familiarity with electronic quality management and training systems.
• Demonstrated success driving quality system transformation or harmonization initiatives.
• Quality or Regulatory certifications (e.g., ASQ, RAC).
• Excellent analytical, communication, and change-management skills.
• Certifications such as Certified Software Quality Engineer (CSQE), Certified Quality Engineer (SQE), Certified Quality Auditor (SQA), or Project Management Professional (PMP).

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.