Director of Tech Quality & Regulatory Compliance

Antler Co; Raynham (MA); On-site; USD 150,000 - 259,000; Full time

Job summary

Johnson & Johnson is hiring a Director, Technical Quality & Compliance, located in West Chester or Raritan NJ, Palm Beach Gardens or Raynham. The role provides strategic leadership for Medical Device Regulatory activities and ensures governance across the product lifecycle.

It strengthens regulatory capabilities, enables digital transformation, and supports global regulatory readiness within DePuy Synthes as part of the transition, collaborating with senior leaders and regional teams.

Qualifications

• 10–12 years leading GxP computerized systems validation (CSV) in regulated industries.
• Deep understanding of GxP regulations, data integrity, SDLC governance, validation lifecycle management, e-records/signatures, audit trails, and inspection readiness.
• Knowledge of global cGMP regulations and computerized systems requirements including regulatory expectations.

Responsibilities

• Ensure J&J quality standards and global regulatory requirements are met.
• Involve quality early in design and development activities; build quality into work products and controls.
• Provide TQ&C guidance to project teams and lead end-to-end quality for systems in scope.

Skills

GxP compliance

CSV

Regulatory affairs

Quality systems

Leadership

SDLC governance

Audit readiness

Data integrity

Education

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

Tools

QMS software

Quality documentation tools

Job description

Johnson & Johnson is hiring a Director, Technical Quality & Compliance, located in West Chester or Raritan NJ, Palm Beach Gardens or Raynham. The role provides strategic leadership for Medical Device Regulatory activities and ensures governance across the product lifecycle.

It strengthens regulatory capabilities, enables digital transformation, and supports global regulatory readiness within DePuy Synthes as part of the transition, collaborating with senior leaders and regional teams.