Senior Director, Quality

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

Senior Director, Quality

Lenoir, NC | Pharmaceutical Manufacturing | Onsite

A global biopharmaceutical manufacturer is seeking a Senior Director, Quality to lead Quality Operations across the U.S. organization. This individual will provide leadership across Quality Assurance, Quality Control, Quality Compliance, Product Release, Supplier Quality, and Regulatory Inspection Readiness while serving as a key member of the site leadership team.

Key Responsibilities

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

Qualifications

• 15+ years of pharmaceutical GMP experience
• Progressive leadership experience within Quality Assurance and Quality Operations
• Experience leading FDA inspections and regulatory interactions
• Strong background overseeing Quality Systems, Compliance, and Product Release
• Prior leadership responsibility for QA and QC organizations
• Proven success leading large cross-functional teams in commercial pharmaceutical manufacturing environments

Preferred

• Senior Director, Director, VP Quality, or Head of Quality experience
• Sterile, biologics, vaccines, or highly regulated pharmaceutical manufacturing experience
• Experience managing complex quality organizations and regulatory initiatives