Manager of Commercial Quality Control

Waltham, MA

Posted: 08/27/2018 Employment Type: Contract Industry: Life Sciences Job Number: 227211

 
Manager of Commercial Quality Control (QC)
3-6 month contract
Waltham, MA

Top Skills:
• HPLC/Chromatography experience 
• Bench top wet chemistry experience
• QC Data Review
• Investigations experience

Desired Skills:
• Experience working in a virtual environment
• Small molecule experience 

The Manager, Commercial Quality Control is responsible for assisting in the implementation of the Quality Control function in support of commercial operations.  The Manager will assist in the day-to-day oversight of analytical testing at contract laboratories and contract manufacturing facilities for testing on commercial pharmaceutical products and Active Pharmaceutical Ingredients (API). The individual will interact with internal multidisciplinary teams to ensure successful delivery schedules of analytical test reports or certificates. This includes assisting with QC checks and preparation of regulatory filings (Supplements and Annual Reports).

Job Requirements
• BS in a scientific area with 8+ years’ experience (or MS/PhD with 5+ years’ experience) in the pharmaceutical/bio-pharm manufacturing industry with at least 2 of those years at the QC manager level
• Knowledge of analytical testing concepts and current cGMPs including laboratory controls and good documentation practices
• Proven ability to manage projects and work with cross-functional teams comprised of internal and/or external contacts
• Experience building relationships and working with CMOs
• Working knowledge ICH quality guidance, EU and FDA drug manufacturing regulations
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