Job Function:
Quality
Job Sub Function:
Quality Systems
Job Category:
Professional
All Job Posting Locations:
New Brunswick, New Jersey, United States of America, 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 West Chester or Raritan NJ, Palm Beach Gardens or Raynham.
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.
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
- 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
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.
Qualifications
Education:
- A Bachelor’s degree in Computer Science, Information Systems, Business Administration or another related field is required; 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
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#DePuySynthesCareers
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
The anticipated base pay range for this position is :
$150,000.00 - $258,750.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off 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 period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
Additional information can be found through the link below.
Co-Ops and Intern Positions: Please use the following language:
Co-Ops/Interns are eligible to participate in Company sponsored employee medical benefits in accordance with the terms of the plan.
Co-Ops and Interns are eligible for the following sick time benefits: up to 40 hours per calendar year; for employees who reside in the State of Washington, up to 56 hours per calendar year.
Co-Ops and Interns are eligible to participate in the Company’s consolidated retirement plan (pension).
Positions Represented by CBA: Please use the following language:
This position is eligible for benefits to include medical, dental, vision and time off, as well as any others as provided for in the applicable Collective Bargaining Agreement.
The following link to general company benefits information MUST also be included in the posting: Please use the following language:
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
