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Manager I/ Quality Assurance

at Company: Millennium Pharmaceuticals, Inc. in Job Category: Quality Assurance
posted on 10/10/08 12:00am

Breakthrough Careers!
A career at Millennium comes with something no other company can offer: a community of people with diverse talents and backgrounds, all dedicated to the discovery and development of therapies that can change the world - one patient at a time. Our casual but focused environment fosters the free exchange of ideas, encourages collaborative research, and sparks discovery of innovative solutions in science and business. At Millennium, we're big on results, not formality.
As a member of Investigational Quality Assurance, the QA Manager will be responsible for batch review/release of MPI finished goods, working with Global Investigational Supply Operations in distribution-related activities, and provide support for investigations, deviations and other quality systems as they relate to Investigational materials.
The successful candidate will ensure that all finished goods intended for use in clinical trials are manufactured in accordance with FDA, ICH and global GMP requirements as well as Millennium Corporate Quality standards.

In addition, the QA Manager will assist Investigational QA Management in the oversight of drug substance and drug product manufacturing performed at approved vendors for Millennium.

Reporting to Investigational Quality Assurance Management, this individual will hold significant responsibilities in a team environment. cGMP knowledge and industry experience will be critical in performing assessments of deviations/investigations, reviewing & approving batch records for label and packaging of Finished Goods, providing support for Regulatory Filings, regulatory inspections and GMP audits of vendors.

Internal interaction with members of Investigational Quality Control, Analytical Development, and Supply Operations as well as external interaction with Contract Manufacturers will be part of the daily routine. As a representative of Investigational QA, this QA Manager may be required to travel to domestic and international locations, intermittently, up to 25% of their time.

BASIC QUALIFICATIONS: Bachelors (or equivalent) and 6+ years of relevant GMP compliance experience (2+ years in QA) or Masters and 4+ years experience of relevant GMP compliance experience (2+ years in QA). Ability to simultaneously support multiple projects and adapt to changing priorities.

PREFERRED QUALIFICATIONS: Must have solid understanding of applicable regulations and guidance's and strong communication skills. Previous experience working with or for a Contract Manufacturer and performing Internal or External compliance audits is desirable. Involvement with labeling, packaging, and distribution of CTM/IMP to support Global Clinical Trials is a plus. Must take initiative and make decisions with minimal supervision as well as identify complex problems and consistently propose solutions

Please apply directly to www.millennium.com
Requistion # 5560BR

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