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Sterling Life Sciences, Specialists in Pharmaceuticals, Healthcare and BioTech Recruitment
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 Job #02943 Email this job to a friend
About our client
Our client is a leading producer of active pharmaceutical ingredients that has recently experienced significant growth. The company has an experienced management team, state-of-the-art facilities and a pristine track record with the FDA. This is a great situation for a candidate that is pursuing a challenging and visible opportunity with a world-class employer.
Position Location
Director of Quality Rhode Island
Salary
Highly competitive package, commensurate with experience
Responsibilities
1) Oversee daily QA activities and cGMP compliance related to manufacturing, packaging, control as well as distribution of active pharmaceutical ingredients
2) Develop procedures to ensure timely and well-documented technology transfer procedures along with IND, scale-up and NDA/MAA filings
3) Work closely with Corporate Quality Assurance and site management to ensure key issues related to cGMP compliance are addressed
Requirements
1) Advanced degree in Analytical Chemistry or a related field (Ph. D. preferred)
2) 15+ years of industry experience (API manufacturing preferred)
3) 10+ years of QA experience in GMP
4) Personnel management experience with recent experience in managing a team of at least 5 people
5) Familiarity with all applicable regulations and experience in dealing with FDA
6) Superb communication skills
7) Ability to work collaboratively with department managers and product teams to provide counsel on cGMP as well as system issues

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