Director, Technical Quality & Compliance

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Quality Systems

Job Category:

Professional

All Job Posting Locations:

Bogotá, Distrito Capital, Colombia, Palm Beach Gardens, Florida, United States of America, Raritan, New Jersey, United States of America, Raynham, Massachusetts, United States of America, West Chester, Pennsylvania, United States of America

Job Description:

DePuy Synthes is recruiting for a Director, Technical Quality & Compliance, located in Bogotá or Palm Beach Gardens or Raynham or West Chester or Raritan.

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 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. 

 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 https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource. 

  

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Job Overview 

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.

 

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

 

Qualifications 

Education: 

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

Experience and Skills: 

Required: 

• 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:

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. 

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

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. 

 

 

Required Skills:

 

 

Preferred 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