Senior Director, 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

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Worksite address

lenoir, NC, 28645, US

Who can apply

Review the original listing for work authorization, qualifications and employer requirements.