Description
Job description
The Associate Director/Director of Quality Assurance is responsible for coordinating and managing the day to day activities of the Quality Assurance department. The position will lead the QA organization as the organization moves from clinical GMP manufacturing, through regulatory approval, and into commercial production. Develops, implements and maintains quality systems required for commercial operations from cGMP and operational efficiency perspectives.
Prepares for, manages and leads regulatory inspections. Ensures the site is continuously ready for regulatory audits / inspections.Manages QA support for the review and approval of documentation such as batch records, process and equipment validation protocols and reports, product specifications and change controls.Develops and facilitates the execution of internal and external audit plans to verify that production, testing facilities and systems are compliant with SOP's, GMP's and other regulatory guidelines.Provides expertise and guidance in interpreting existing and emerging governmental regulations, agency guidelines and internal policies to assure compliance.Partners with Manufacturing and QC to enhance the GMP compliance profile of the site by ensuring the timely closure of investigations and implementation of appropriate corrective actions.Authors, reviews and / or approves internal quality documents (SOPs, deviations, CAPAs, change controls, etc.) and external regulatory agency documents.
Desired Skills and Experience
- BS in Chemistry or Life Sciences
- 15 + years of relevant experience in a biotechnology or FDA/GMP environment
- Experience with QA/GMP Compliance in clinical/commercial manufacturing.
- Ability to understand and apply GMP regulations as they relate to manufacturing, raw materials, testing and facility operations
- Strong interpersonal, written and oral communication skills
To find out more about Real please visit www.realstaffing.com
