Director, Technical Quality & Compliance

Johnson & Johnson • New Brunswick, NJ

7d • Hybrid

About The Position

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. Johnson & Johnson announced plans to separate our Orthopedics business to establish a standalone orthopedics 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.

Requirements

• 10-12 years of experience leading GxP computerized systems validation (CSV) within pharmaceutical, medical device, biotech industry, or other regulated industries.
• Deep understanding of GxP regulations and compliance requirements, including data integrity, SDLC governance, validation lifecycle managements, electronic records/signatures, audit trails, and inspection readiness.
• Thorough knowledge of global cGMP regulations and computerized systems requirements including:
• A Bachelor’s degree in Computer Science, Information Systems, Business Administration or another related field is required.
• English required.

Nice To Haves

• 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.
• Advanced degree is preferred.
• Additional European languages preferred.
• Quality or Regulatory certifications preferred but not required.
• Certified Software Quality Engineer (CSQE), Certified Quality Engineer (SQE), Certified Quality Auditor (SQA), Project Management Professional (PMP) or similar.

Responsibilities

• Ensure that all J&J quality standards and global regulatory requirements are being met.
• Ensure that building and execution activities include early involvement of quality in the design and development activities, building quality into the work product, building controls within the application/solution, and use of automation whenever feasible.
• Provide TQ&C expertise/guidance to the project teams.
• Drive the implementation and maintenance of systems to be delivered on time, within budget and with high quality.
• Provide end-to-end Technology Quality leadership support to projects and base business support teams across applications and cloud infrastructure.
• Lead the quality approach for systems and ensure teams are accountable for delivering on an end-to-end support model for systems in scope.
• Partner with Regional Leads in support of the TQ&C Operating Model.
• Lead global teams with unique skills in cross-functional environments.
• Provide an environment which encourages the company’s credo and the value of a diverse workforce.
• Serve as a trusted partner across the Technology Quality & Compliance organization, requiring collaboration skills at the senior leadership level, both internally and externally.

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• 10 days Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year
• Consolidated retirement plan (pension)
• Savings plan (401(k))
• Long-term incentive program
• Medical benefits
• Dental benefits
• Vision benefits

What This Job Offers

• Job Type: Full-time
• Career Level: Director