Senior Director, Quality Operations – Onsite Pharma

EPM Scientific; Lenoir (NC); On-site; USD 180,000 - 260,000; Full time

Job summary

EPM Scientific in Lenoir, NC is seeking a Senior Director, Quality to lead Quality Operations across the U.S. organization.

This onsite role directs QA, QC, Quality Compliance, Product Release, and Supplier Quality, while partnering with site leadership to ensure patient safety and product quality. The ideal candidate has 15+ years of GMP experience, proven cross-functional leadership, and a track record of managing FDA inspections and regulatory interactions.

Qualifications

• 15+ years of pharmaceutical GMP experience.
• Progressive leadership in Quality Assurance and Quality Operations.
• Experience leading FDA inspections and regulatory interactions.
• Strong background in Quality Systems, Compliance, and Product Release.
• Prior leadership of QA and QC organizations.
• Proven track record directing large cross-functional teams in pharma manufacturing.

Responsibilities

• Lead QA, QC, Quality Compliance, Product Release, and Supplier Quality.
• Ensure compliance with FDA regulations, cGMP, and internal standards.
• Oversee site quality systems including deviations, CAPAs, changes, complaints, audits.
• Lead FDA inspections, customer audits, and regulatory interactions.
• Drive quality culture, continuous improvement, and operational excellence.
• Partner with manufacturing and site leadership to support objectives while ensuring patient safety.
• Develop and mentor quality leadership teams.

Skills

Leadership

Quality Assurance

Regulatory Compliance

GMP

Quality Systems

FDA Inspections

Cross-functional Leadership

Product Release

Supplier Quality

Job description

EPM Scientific in Lenoir, NC is seeking a Senior Director, Quality to lead Quality Operations across the U.S. organization.

This onsite role directs QA, QC, Quality Compliance, Product Release, and Supplier Quality, while partnering with site leadership to ensure patient safety and product quality. The ideal candidate has 15+ years of GMP experience, proven cross-functional leadership, and a track record of managing FDA inspections and regulatory interactions.