Director Of QA ( GxP)

About the role

The Director of QA Compliance will lead the commercial QA Compliance function and ensure ongoing inspection readiness across audits, supplier quality, regulatory inspections, management review, and quality-related licenses. This role involves providing strategic Quality Systems oversight and collaborating cross-functionally to identify, escalate, and resolve compliance risks. It offers an opportunity to lead and develop a commercial QA Compliance function with broad ownership across audit programs, supplier quality, inspection readiness, and management review. It is a high-visibility leadership role with exposure to Senior stakeholders, cross-functional partners, and regulated third-party networks. The position is remote, with a preference for candidates located on the East Coast, but flexibility is available for highly qualified individuals. It is a Contract position based out of Durham, NC. The role is anticipated to close on Sep 30, 2026.

Responsibilities

• Lead QA Compliance governance and maintain continuous inspection-readiness across commercial Quality Systems.
• Manage internal, clinical, and supplier audit programs, including planning, execution, reporting, CAPA follow-up, effectiveness checks, and risk-based prioritization.
• Oversee supplier qualification, periodic review, quality agreements, performance monitoring, issue escalation, and remediation tracking.
• Serve as quality lead for regulatory inspections, involving readiness planning, hosting support, response coordination, commitment tracking, and remediation.
• Support Management Review and Quality Council forums through metrics, trend analyses, risk assessments, and executive-level compliance summaries.
• Monitor regulatory intelligence and translate global regulatory changes and enforcement trends into practical Quality System updates.
• Lead or oversee compliance activities, quality trend reviews, compliance metrics, and process improvements to enhance QMS effectiveness and scalability.

Requirements

• Bachelor’s degree in life sciences, pharmacy, chemistry, biology, engineering, or a related scientific discipline; advanced degree preferred.
• 15+ years of progressive experience in Quality Assurance, Quality Compliance, or Quality Systems in pharmaceutical, biotechnology, or regulated life sciences.

Qualifications

• Prior leadership experience at Manager, Senior Manager, Associate Director, or Director level in commercial Quality Systems or QA Compliance programs.
• Experience with commercial-stage quality systems including audits, management review, metrics, inspection readiness, and supplier oversight.
• Working knowledge of FDA, EMA, PMDA preferred.
• Familiarity with ICH, GxP, GMP, GCP, and commercial quality requirements, focusing on inspection support and regulatory submission QC/Support.

Skills

• BIMO Experience
• Excellent written and verbal communication skills, with the ability to present complex compliance topics to Senior leaders and cross-functional stakeholders.

Pay

The pay range for this position is $125.00 - $135.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Benefits

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)