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.

Locations: Bogotá, Distrito Capital, Colombia; Palm Beach Gardens, Florida, USA; Raritan, New Jersey, USA; Raynham, Massachusetts, USA; West Chester, Pennsylvania, USA.

Key Responsibilities

• This role must ensure that all J&J quality standards and global regulatory requirements are being met.
• This role ensures 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.
• The role provides TQ&C expertise/guidance to the project teams.
• This individual must drive the implementation and maintenance of systems to be delivered on time, within budget and with high quality.
• This individual must provide end-to-end Technology Quality leadership support to projects and base business support teams across applications and cloud infrastructure.
• This individual will lead the quality approach for systems and ensure teams are accountable for delivering on an end-to-end support model for systems in scope.
• Partners with Regional Leads in support of the TQ&C Operating Model.
• This role will lead global teams with unique skills in cross‑functional environments.
• This role will provide an environment which encourages the company’s credo and the value of a diverse workforce.
• This role serves as a trusted partner across the Technology Quality & Compliance organization, requiring collaboration skills at the senior leadership level, both internally and externally.

Required Experience and Skills

• 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 management, electronic records/signatures, audit trails, and inspection readiness.
• Thorough knowledge of global cGMP regulations and computerized systems requirements.
• Preferred 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.

Education Qualifications

• A Bachelor’s degree in Computer Science, Information Systems, Business Administration or another related field is required; an advanced degree is preferred.

Other Language

English required; additional European languages preferred.

Travel

Moderate international travel.

Certifications

• 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.

Skills

• Analytical Reasoning
• Analytics Dashboards
• Compliance Management
• Data Gathering and Analysis
• Data Quality
• Incident Management
• Performance Measurement
• Quality Control (QC)
• Quality Management Systems (QMS)
• Quality Services
• Quality Standards
• Risk Management
• Standard Operating Procedure (SOP)
• System Integration
• Systems Analysis
• Tactical Planning
• Technical Credibility