Interim QA Director – Oral Solid Dose (Contract)

Inc. (Vti)

High Point (NC)

On-site

USD 180,000 - 240,000

Full time

9 days ago
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Job summary

VTI Life Sciences is seeking an Interim Senior QA Director for an Oral Solid Dose facility in North Carolina. The role requires leading the site’s Quality function, maintaining PQS effectiveness, and ensuring regulatory compliance during a 3–6 month contract.

The candidate will oversee batch disposition, quality systems, and regulatory inspections, interfacing with site leadership and CDMO clients to drive quality excellence.

Qualifications

  • Minimum 12 years of progressive pharmaceutical QA/GMP experience.
  • 3–5 years of Quality leadership at Senior Manager/Director level or equivalent.
  • Experience with OSD manufacturing and regulatory inspections.
  • Strong knowledge of 21 CFR Parts 210/211, EU GMP guidelines, ICH Q9/Q10.

Responsibilities

  • Serve as the senior Quality voice on the Site Leadership Team.
  • Provide quality oversight and risk-based decision making for manufacturing operations.
  • Authorize batch disposition and product release.
  • Escalate or halt manufacturing activities when quality or regulatory risks arise.
  • Develop and execute site Quality priorities aligned with regulatory expectations.
  • Lead PQS oversight and improvements (deviations, investigations, CAPA, change control).
  • Support CDMO client audits and regulatory interactions.
  • Lead quality organization and drive a proactive quality culture.

Skills

Quality leadership
Regulatory awareness
GMP expertise
Decision making
Site leadership

Education

Bachelor's degree in Pharmaceutical Sciences or related

Job description

VTI Life Sciences is seeking an Interim Senior QA Director for an Oral Solid Dose facility in North Carolina. The role requires leading the site’s Quality function, maintaining PQS effectiveness, and ensuring regulatory compliance during a 3–6 month contract.

The candidate will oversee batch disposition, quality systems, and regulatory inspections, interfacing with site leadership and CDMO clients to drive quality excellence.

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