Quality Assurance Manager

Our client company in the Greater NYC region continuously strives for excellence by seeking further advancement from their already-leading position in their specialized arena.  They are in search of a highly-motivated Manager of Quality Assurance who carries the same vision of continual success and has a great deal of experience in working with CAPA and customer complaints.  The suitable candidate must have a proven track record in managing Quality Assurance policies, systems, and regulatory compliance in a Pharmaceutical/Biotechnology/Medical Device setting. Other responsibilities include:

 Investigate, assess the impact of, and resolves minor, major and critical defects that may occur during manufacturing, testing, or distribution of products, or during the administration of quality systemsProvide leadership to the QA staff in the areas of personnel development; compliant documentation and record review; evaluation of EICs, graphics, and other Change RequestsWrite and revise Quality systems SOPS as necessary to maintain compliance to cGMPs, QSR’s, etc…Conduct GXP trainingAssist with audit preparation and any post-audit follow-upParticipate as a technical expert in audits of quality and manufacturing operationsIdentify areas of potential risk and assist the Quality team in developing and implementing plans to address themGuide Lead Inspectors and Inspectors in product release and site record/batch control

 

REQUIREMENTS:

 Minimum of a BS/BA degree in Biology, Chemistry, Engineering, or related sciences Minimum of 7~10 yrs. Of experience in Pharma/biotech/medical device AT LEAST 5 yrs of experience in QA or QC department