What are the responsibilities and job description for the Site Quality Manager position at ACE Partners?
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.
Salary : $150,000 - $190,000