Director of Quality Assurance – Aseptic Pharma – FILLED

The Wellington Group has been engaged to find a seasoned Director of Quality Assurance – Aseptic Pharma for the Western, NC area. This is a great opportunity to work for one of North Carolina’s growing biotech companies with a focus on current and future medical technologies.

The Director of Quality Assurance will be the lead person for the Quality Assurance Department. All QA functions will report directly to the Director.

The QA Director will be responsible for managing all Quality Assurance activities to include QS, GLP and GMP training and standards, SOPs, Document Control, Audits and support regulatory and quality submissions, Manufacturing, Materials, QA Labs, FDA visits and any OOS challenges. This position will have responsibility for QC Chem, QC Micro, QA Release, Configuration, and the Animal Facility. The Director will be responsible for ensuring the quality of the products produced.

Responsibilities include:
• Will be the lead person for the Quality Assurance Department
• Experience with an aseptic facility which is subject to FDA guidelines and inspections
• Oversee Quality System activities including Documentation Control, Internal Audits, Quality Records maintenance, and Management Review
• Interface with US and International compliance and certification authorities as necessary
• Lead efforts toward continuous Quality improvements
• Need someone who is “hands on” and someone with strong people skills

The qualified candidate will have:
• Minimum of 5 to 10 years in pharmaceuticals or biologics
• 4-year degree required, MS degree preferred
• FDA and USDA experience is a must.
• Broad knowledge of cGMP, ISO requirements for pharmaceuticals
• Demonstrated ability to manage staff and variable workloads

Permanent position with an employee centered company offering great benefits, salary, bonus and relocation assistance.

Don’t wait, apply with The Wellington Group today!
(all information will be held in the strictest of confidence)

The Wellington Group ( ) 910-338-2795

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