Site Quality Manager

Site Quality Manager

$150,000 - $190,000 + bonus

Kentucky, US

We're partnered with a GMP-regulated manufacturer to find a Senior Site Quality Manager to lead site-wide quality strategy and compliance.

This is a high-impact leadership role reporting into senior site leadership, with direct oversight of 3 direct reports and full ownership of the site's quality function.

What you'll do:

• Lead and develop a team of three Quality Managers, setting site quality strategy alongside Operations and senior leadership
• Act as site Management Representative for all quality and compliance matters
• Own inspection readiness and lead FDA and customer audits, ensuring timely closure of observations
• Drive compliance with FDA 21 CFR 210/211, ICH Q7, ISO 9001, IPEC, and FSSC 22000
• Oversee core quality systems: investigations/CAPA, Management of Change, training compliance, and internal audit
• Provide strategic oversight of QC lab operations, including OTIF performance and nonconforming material disposition (MRB)
• Guide digital transformation across LIMS, EBR, and eQMS platforms
• Own the quality department budget and Integrated Operating Plan (IOP)
• Champion a strong GMP/GDP culture built on right-first-time execution

What you'll bring:

• Bachelor's degree in Life Sciences, Chemistry, Engineering, or a related field (Master's a plus)
• 5+ years in a GMP-regulated industry (pharmaceutical, biotech, or food/ingredient manufacturing)
• 5+ years leading managers or multiple functional teams
• Track record leading site-level quality programs and regulatory inspections
• Strong grasp of global regulatory frameworks (FDA, ICH, ISO, FSSC, IPEC) and digital quality systems

If you're a Quality leader ready to take ownership of a site's full quality function and drive a culture of compliance and continuous improvement, we'd love to hear from you.

Apply now or reach out directly to learn more.