Director, Technical Quality & Compliance

Johnson & Johnson Co.; Raritan (NJ); On-site; USD 150,000 - 259,000; Full time

Job summary

Johnson & Johnson's DePuy Synthes seeks a Director of Technical Quality & Compliance to lead regulatory activities for medical devices. This role shapes governance, data integrity, and submissions across the product lifecycle, guiding digital transformation and global readiness.

You will steer quality systems, drive cross-functional collaboration, and foster a diverse, high-performing team while aligning with corporate credo and compliance standards.

Qualifications

• 10-12 years of experience leading GxP computerized systems validation (CSV) within regulated industries.
• Deep understanding of GxP regulations, data integrity, SDLC governance, validation lifecycle management, e-records/signatures, audit trails, and inspection readiness.
• Thorough knowledge of global cGMP regulations and computerized systems requirements.

Responsibilities

• Ensure all J&J quality standards and global regulatory requirements are met.
• Provide TQ&C expertise to project teams and drive end-to-end quality leadership.
• Lead implementation and maintenance of systems delivered on time, within budget, and with high quality.
• Support projects and base business teams across applications and cloud infrastructure.
• Collaborate with regional leads to strengthen the TQ&C Operating Model.

Skills

GxP CSV leadership

Regulatory compliance

SDLC governance

Data integrity

Regulatory submissions

Education

Bachelor's degree in CS/IS/Business Admin or related field

Advanced degree preferred

Job description

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

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

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.

#LI-Hybrid

#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.

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

Co‑Ops and Intern Positions: Please use the following language:

Co‑Ods/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

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

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.

#LI-Hybrid

#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.