Site Quality Manager

ACE Partners; Kentucky; On-site; USD 120,000 - 180,000; Full time

Job summary

ACE Partners is seeking a Senior Site Quality Manager to lead site-wide quality strategy and compliance across our GMP-regulated facility. This high-impact leadership role reports into senior site leadership, with direct oversight of 3 direct reports and full ownership of the site's quality function, including QA and QC operations, audits, and continuous improvement initiatives.

You will drive FDA and customer audits, oversee CAPA, and lead digital quality systems integration (LIMS, EBR, eQMS)

Qualifications

• Bachelor's degree in Life Sciences, Chemistry, Engineering.
• 5+ years in GMP-regulated industry.
• 5+ years leading managers or multiple teams.
• Proven track record managing site-level quality programs and regulatory inspections.
• Strong knowledge of FDA, ICH, ISO, FSSC, IPEC and digital quality systems.

Responsibilities

• Lead and develop a team of three Quality Managers and set site quality strategy.
• Act as site Management Representative for quality and compliance.
• Own inspection readiness and lead FDA and customer audits.
• Drive compliance with FDA 21 CFR 210/211, ICH Q7, ISO 9001, IPEC, and FSSC 22000.
• Oversee core quality systems: investigations/CAPA, Change Control, training, and internal audits.
• Provide strategic oversight of QC lab operations and MRB.
• Champion GMP/GDP culture and right-first-time execution.

Skills

Leadership

Regulatory compliance

Quality management

Audits

People management

Education

Bachelor's degree in Life Sciences, Chemistry, Engineering

Tools

LIMS

EBR

eQMS

Audit management software

Job description

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.