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Posted: 4 years ago
Manager, Quality Assurance | Boston
 Job Summary
Location Of Gig:
Boston
Country:
Gig Categories:
Other Nursing
Last Updated on:
05-23-2014

 Company Information
Intalex

Company:
Intalex
Description:
We connect recruitment professionals from around the world on a single trading platform...
Contact:
laurence@intalex.com
Address:
Intalex Ltd.
21 Clanwilliam Square,
Grand Canal Quay,
Dublin 2, Ireland

Tel: +353 1 4004400
Email: info@intalex.com
Phone:
Tel: 00353 1 4004400
Website:
http://www.intalex.com
 Job Description
Manager Quality Assurance
Cambridge (Boston MA)
Permanent - $120000
Life Sciences
Added on 10/04/2013
About the company

Our client is a global biopharmaceutical company that develops innovative oncology medicines to treat a variety of cancers.

Job description

Our client is looking for a Manager Quality Assurance to oversee developmental programs for multiple compounds in various stages of development. The Manager Quality Assurance will provide Quality support for biologics and small molecule products in the US and abroad.

Some of the core responsibilities include but are not limited to:
• Provide Quality support for multiple developmental biologics products
• Ensure drug substance drug product and finished products for use in clinical trials meet FDA ICH and GMP guidelines
• Review and approve deviations investigations CAPA s OOS investigations SOP s and other applicable quality documents as applicable
• Manage external vendors and CMOs including CMO site visits as required
• Maintain relationships with all internal stakeholders including CMC the team
Who we are looking for

• BS in life science or related field required; advanced degree a plus
• Minimum of 5 years Quality Assurance experience in the pharmaceutical industry
• 5 years experience working in a GMP environment
• Demonstrated working knowledge of FDA EMA and ICH GMP requirements
• Experience with Quality for biologics products preferred
• Ability to work independently while actively contributing to project teams