Global VP of Quality Systems & Compliance

Integra LifeSciences; Princeton (NJ); On-site; USD 225,000 - 316,000; Full time

Job summary

Integra LifeSciences seeks a VP, Corporate Quality Systems to design and oversee the global quality system. You will lead cross-functional teams, drive remediation, and ensure compliance with FDA, ISO 13485, CMDR, MDR, MDSAP, and JPAL across sites.

You will report to the Chief Quality Officer and manage a corporate Quality system team including CAPA, Doc Control, Training, and Post Market Surveillance, with up to 50% travel.

Qualifications

• Bachelor's degree required in engineering/science; master's preferred.
• 18+ years leading a team or equivalent management experience.
• Experience in highly regulated industries, medical device/pharma preferred.
• Knowledge of FDA regulations, ISO 13485, CMDR, MDR, MDSAP, JPAL.

Responsibilities

• Build a high-performance quality culture and team across manufacturing and distribution.
• Design, implement and oversee Integra's Global Quality System.
• Lead interactions with regulatory bodies and prepare responses with the CPO.

Skills

Leadership

Regulatory knowledge

Cross-functional collaboration

Strategic thinking

Influence senior leadership

Education

Bachelor's degree in engineering or science

Master’s degree preferred

Tools

Quality Management System (QMS)

CAPA

Document Control

Job description

Integra LifeSciences seeks a VP, Corporate Quality Systems to design and oversee the global quality system. You will lead cross-functional teams, drive remediation, and ensure compliance with FDA, ISO 13485, CMDR, MDR, MDSAP, and JPAL across sites.

You will report to the Chief Quality Officer and manage a corporate Quality system team including CAPA, Doc Control, Training, and Post Market Surveillance, with up to 50% travel.