Director of Technical Quality & Regulatory Excellence

Johnson & Johnson MedTech; Raynham (MA); On-site; USD 150,000 - 259,000; Full time

Benefits offered by this job

Vacation 120 hours

Parental Leave

Sick time

Retirement plan & benefits

Job summary

Johnson & Johnson is recruiting a Director, Technical Quality & Compliance, to lead regulatory activities for GxP systems and ensure governance across the product lifecycle. The role strengthens regulatory capabilities, enables digital transformation, and supports readiness within DePuy Synthes as part of the planned separation strategy.

Located in West Chester, Raritan NJ, Palm Beach Gardens or Raynham, this position requires 10–12 years of CSV leadership, advanced quality certifications, and

Qualifications

• Bachelor's degree required; Advanced degree preferred.
• 10–12 years of experience leading GxP computerized systems validation (CSV).
• Deep understanding of GxP regulations including data integrity, SDLC governance, validation lifecycle management, electronic records/signatures, audit trails and inspection readiness.

Responsibilities

• Lead regulatory activities for GxP CSV across the product lifecycle.
• Provide governance and data-driven insights to support regulatory submissions and decision-making.
• Drive quality system transformation and harmonization initiatives.
• Ensure timely, within-budget delivery of high-quality systems and projects.
• Partner with global teams and regional leads to support the TQ&C Operating Model.
• Serve as senior advisor for quality and compliance in cross-functional settings.

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

Education

Bachelor's degree in Computer Science, Information Systems, Business Administration or related field

Advanced degree preferred

Job description

Johnson & Johnson is recruiting a Director, Technical Quality & Compliance, to lead regulatory activities for GxP systems and ensure governance across the product lifecycle. The role strengthens regulatory capabilities, enables digital transformation, and supports readiness within DePuy Synthes as part of the planned separation strategy.

Located in West Chester, Raritan NJ, Palm Beach Gardens or Raynham, this position requires 10–12 years of CSV leadership, advanced quality certifications, and