Sr. Advisor, Quality Assurance ( QA ) 8/16/2016
JOB DESCRIPTIONAPPLY SENIOR ADVISOR QUALITY ASSURANCE (QA): (NC)
Our client offers a broad range of cost effective Process R&D services including route development, optimization and manufacture of clinical and commercial quantities of pharmaceutical intermediates and API's. They maintain USFDA inspected facilities in China for cGMP production from kg to multi-ton levels. Their expertise lies in developing economically and safely feasible routes for scale-up of technically complex API's, with the added advantage of in-house raw materials manufacturing to control availability and lead-times. From the initiation of a project, the development of synthetic process through to manufacturing is supported by our scale-up team, meeting full GMP compliance and regulatory requirements. For projects at late phase of development, their commercial team can handle Technical Transfers of existing process into manufacturing facilities.
CANDIDATE WILL REPORT TO VICE PRESIDENT FOR QUALITY ASSURANCE AND SUPPORT ALL QA EFFORTS COMPANY WIDE, INCLUDING DEVELOPING AND IMPROVING UPON EXISTING QA PROGRAMS, TRAIN EMPLOYEES, SET POLICIES, IMPLEMENT QA MANAGEMENT SYSTEMS, LEAD ON REGULATORY AUDITS, AND ASSURE GOVERNMENTAL AND CUSTOMER COMPLIANCE AND RISK ASSESSMENT NEEDS ARE MET IN OUR CMO BUSINESS FOR CLINICAL AND COMMERCIAL API MANUFACTURING. ACTIVELY PROMOTE THE DEEPENING OF ORGANIZATION'S QUALITY CULTURE.
* B.S. CHEMISTRY OR RELATED DEGREE
* MINIMUM 7+ YEARS OF EXPERIENCE IN QA FROM A CMO OR A PHARMACEUTICAL COMPANY, BILINGUAL ENGLISH AND MANDARIN-SPEAKING A PLUS BUT NOT REQUIRED, WITH BACKGROUND IN MANUFACTURING PREFERRED.
* Based in the US, some travel to China