Head Of QA and Compliance

In this key position, the individual will develop, implement, manage, audit, and maintain GxP (cGMP, GCP, and GLP) quality systems and will work across all disciplines (e.g., manufacturing, clinical development, research, and regulatory affairs) to ensure that the Company's ongoing development program maintains regulatory compliance with health authority requirements (local, state, federal, and international). The ideal candidate should have experience in the area of cell therapy and be aware of the pertinent regulations. The individual should also have relevant experience gained in an equivalent industry position.

Requirements

* Lead the strategic development, management, and maintenance of a cGXP compliant document control system
* Lead the establishment of Standard Operating Procedures (SOPs) and updates to ensure compliance standards are met
* Lead external (contract manufacturers, suppliers, vendors) and internal audits to ensure compliance with regulatory authorities, GxP regulations, ICH guidelines, and Company standards
* Review and approve batch record packets provided to manufacturing sites for the Company's patient-specific product batches

* Life Sciences degree

* At least 5 years of experience managing the quality aspects of new cell therapy products, including manufacturing and technical qualification, analytical testing, and product release in a clinical stage pharmaceutical or biotechnology company

To find out more about Real Staffing please visit www.realstaffing.com