Interim QA Director

Interim Senior QA Director – Oral Solid Dose

VTI Life Sciences is seeking an experienced pharmaceutical Quality professional to serve as Interim QA Director for a 6-month assignment supporting an Oral Solid Dose (OSD) pharmaceutical manufacturing facility.

The successful candidate may currently be operating at the Senior Manager, Associate Director, or Director level, but must demonstrate the technical knowledge, leadership capability, judgment, and independence necessary to function as the site's senior Quality leader.

The Interim QA Director will provide Quality leadership and oversight of pharmaceutical manufacturing operations, maintain the effectiveness of the Pharmaceutical Quality System (PQS), support batch disposition and product release, maintain inspection readiness, and provide senior Quality representation to site leadership, regulatory authorities, and CDMO clients.

We offer an opportunity to support our teams of industry subject-matter experts and thought leaders while consulting with leading companies in the Life Sciences industry.

• 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.

Provide Quality oversight for OSD manufacturing operations including, as applicable:

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

Provide Quality oversight of critical product and process controls including:

• 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…