Job Details

QA Program Manager – GCP / GLP / GVP

We are partnered with a well established Medical Device company looking to expand their Quality Assurance team.

They are seeking an experienced QA Program Manager, this individual will support the embedded Quality leadership across clinical, nonclinical, and pharmacovigilance programs from early through late-stage development.

Key Responsibilities

• Lead and conduct GCP, GLP, and GVP audits
• Provide hands-on QA support across study planning, execution, and close-out
• Drive inspection readiness and support global regulatory inspections (FDA, EMA, ICH)
• Lead deviation investigations, root cause analyses, and CAPA implementation
• Oversee and qualify external vendors to ensure ongoing compliance

Profile

• 7+ years' QA experience in pharma, biotech, or medical device
• Strong background supporting clinical, nonclinical, and PV activities
• Proven audit leadership and regulatory inspection support
• Experience in imaging agents, diagnostics, or combination products preferred