Director, Technical Quality & Compliance (Medical Devices)

Antler Co; West Chester (Chester County); On-site; USD 150,000 - 259,000; Full time

Benefits offered by this job

Vacation –120 hours per year

Sick time –40 hours per year

Holiday pay –13 days per year

Parental Leave –480 hours

Volunteer Leave –32 hours per year

Job summary

DePuy Synthes is recruiting for 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 supports global regulatory readiness across the product lifecycle.

The position requires 10–12 years of experience in CSV and GxP, with strong SDLC governance, data integrity focus, and cross‑functional collaboration with senior leaders.

Qualifications

• 10-12 years leading GxP computerized systems validation in regulated industries.
• Deep knowledge of GxP, data integrity, validation lifecycle management and audits.
• Global cGMP regulations and computerized systems requirements.

Responsibilities

• Lead the strategy for Medical Device Regulatory activities and governance.
• Provide TQ&C guidance to project teams and ensure on-time delivery.
• Direct end-to-end quality leadership for applications, cloud infra, and systems.
• Drive quality transformation and harmonization across global teams.
• Collaborate with regional leads and senior stakeholders on operating model.

Skills

GxP compliance

CSV validation

Regulatory knowledge

SDLC governance

Audit readiness

Quality leadership

Global/matrix environment

Quality certifications

Education

Bachelor's degree in Computer Science/Info Systems/Business

Advanced degree preferred

Job description

DePuy Synthes is recruiting for 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 supports global regulatory readiness across the product lifecycle.

The position requires 10–12 years of experience in CSV and GxP, with strong SDLC governance, data integrity focus, and cross‑functional collaboration with senior leaders.