Interim QA Director -

• Location: North Carolina      
• Start Date: October 2026
• Employment Classification: Contract
• Length of Project: 3 - 6 months

• Serve as the senior Quality representative and independent Quality voice on the Site Leadership Team.
• Provide Quality oversight and risk-based decision-making for pharmaceutical manufacturing operations.
• Exercise appropriate Quality authority for batch disposition and product release.
• Escalate or halt manufacturing activities when significant product quality, patient safety, or regulatory compliance risks are identified.
• Develop and execute site Quality priorities aligned with business objectives and regulatory expectations.

• Provide leadership and oversight of the site's Pharmaceutical Quality System (PQS).
• Ensure effective management of:
  • Deviations and investigations
  • CAPA
  • Change control
  • Product complaints
  • Document control
  • Quality Risk Management
  • Management review and Quality metrics
• Ensure investigations identify scientifically sound root causes and that CAPAs are appropriate, effective, and completed in a timely manner.
• Establish priorities and execute plans for reducing Quality System backlogs.

• Granulation
• Blending
• Compression
• Encapsulation
• Coating
• Tablets and capsules
• Granules
• Soft gel products

• Blend and content uniformity
• Dissolution
• Stability programs
• Process validation
• Cleaning validation
• Equipment qualification
• Continued Process Verification (CPV)

• Maintain continuous FDA and regulatory inspection readiness.
• Provide senior Quality leadership during FDA and other regulatory inspections.
• Support responses to regulatory observations and ensure appropriate corrective actions are implemented.
• Maintain compliance with 21 CFR Parts 210 and 211, EU GMP, ICH Q9, ICH Q10, and applicable regulatory expectations.
• Maintain effective site data integrity governance consistent with ALCOA+ principles.

• Serve as a senior Quality interface for pharmaceutical CDMO clients.
• Participate in and support client Quality meetings.
• Lead or support customer and regulatory audits.
• Ensure Quality commitments to clients are appropriately documented, communicated, and completed.

• Lead, coach, and develop the site Quality organization.
• Assess organizational capability, staffing, technical competencies, and leadership needs.
• Establish clear responsibilities, priorities, and accountability.
• Promote a proactive Quality culture emphasizing compliance, scientific decision-making, Quality Risk Management, and continuous improvement.
• Establish appropriate Quality metrics and tiered management processes.

• Bachelor's degree in Pharmaceutical Sciences, Chemistry, Biology, Microbiology, Engineering, Life Sciences, or a related scientific discipline.

• Minimum 12 years of progressive pharmaceutical Quality Assurance and GMP experience within FDA-regulated pharmaceutical manufacturing.
• Minimum 3–5 years of Quality leadership experience at the Senior Manager, Associate Director, Director, Site Quality Head, or equivalent level.
• Demonstrated ability to operate with Director-level responsibility and independent Quality decision-making authority.
• Significant experience in Oral Solid Dose (OSD) pharmaceutical manufacturing.
• Strong working knowledge of 21 CFR Parts 210 and 211, EU GMP requirements, and applicable ICH guidelines, including ICH Q9 and Q10.
• Direct experience with batch record review, batch disposition, and product release.
• Demonstrated experience with pharmaceutical quality systems, including deviations, investigations, CAPA, change control, complaints, document control, and Quality Risk Management.
• Experience supporting or leading FDA inspections, regulatory inspections, and client/customer audits.
• Strong understanding of data integrity and ALCOA+ principles.
• Experience with process validation, cleaning validation, equipment qualification, and continued process verification.
• Demonstrated ability to lead Quality teams and work effectively with Manufacturing, QC, Engineering, Validation, Regulatory Affairs, Supply Chain, and senior site leadership.

• 15+ years of pharmaceutical industry experience.
• Previous experience as a Senior QA Manager, Associate Director of Quality, QA Director, or Site Quality Head.
• Previous experience in a CDMO pharmaceutical manufacturing environment.
• Experience managing Quality organizations supporting multiple products and clients.
• Experience leading FDA inspections and responding to regulatory observations.
• Experience improving underperforming Quality Systems and reducing investigation, deviation, CAPA, and change-control backlogs.
• Experience transitioning responsibilities to a permanent Site Quality Head or successor.

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