Interim QA Director – Oral Solid Dose Manufacturing
Job in
Jacksonville, Onslow County, North Carolina, 28540, USA
Listed on 2026-09-22
Listing for:
United Pharma Technologies Inc
Seasonal/Temporary
position Listed on 2026-09-22
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist, Quality Engineering, QA Specialist - Analyst/Manager
Job Description & How to Apply Below
Role:
Interim QA Director – Oral Solid Dose Manufacturing
Location:
High Point, NC | Onsite
Position Summary:
We are seeking an experienced pharmaceutical Quality professional to serve as an Interim QA Director supporting an Oral Solid Dose (OSD) manufacturing facility. The candidate should have Director-level leadership capability and strong independent Quality decision-making experience.
Key Responsibilities:- Lead site Quality and serve as the senior Quality representative.
- Oversee the Pharmaceutical Quality System, including deviations, investigations, CAPA, change controls, complaints, and Quality Risk Management.
- Provide Quality oversight for OSD manufacturing, including granulation, blending, compression, encapsulation, coating, tablets, and capsules.
- Oversee batch disposition, product release, process validation, cleaning validation, equipment qualification, and CPV.
- Maintain FDA and regulatory inspection readiness and support FDA/customer audits.
- Ensure compliance with 21 CFR Parts 210/211, EU GMP, ICH Q9/Q10, and ALCOA+ data integrity principles.
- Serve as the senior Quality interface for CDMO clients.
- Lead, coach, and develop the site Quality organization while partnering with Manufacturing, QC, Engineering, Validation, and Regulatory teams.
- Drive reduction of Quality System backlogs and continuous improvement.
- Bachelor’s degree in a relevant scientific or engineering discipline.
- 12+ years of pharmaceutical QA/GMP experience in FDA-regulated manufacturing.
- 3–5+ years of Senior Manager, Associate Director, Director, or Site Quality leadership experience.
- Strong OSD manufacturing experience.
- Hands-on experience with batch release, deviations, CAPA, change control, investigations, audits, and inspections.
- Strong knowledge of 21 CFR 210/211, EU GMP, ICH Q9/Q10, and ALCOA+.
- Experience with process/cleaning validation and equipment qualification.
- Strong leadership and cross-functional communication skills.
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