Home > New Jobs > biogen idec - Sr Manager, Supply Chain Quality Job in Cambridge 02142, Massachusetts US

biogen idec - Sr Manager, Supply Chain Quality Job in Cambridge 02142, Massachusetts US

September 2, 2010 Job Posted in New Jobs

Country: USA
Location: NA NA
Total applied: 40

Job TitleSr Manager, Supply Chain QualityLocationCambridge,MARequisition Number11723BRJob DescriptionThis position requires a dynamic individual who will represent Biogen Idec Quality at contract manufacturing facilities.

The scope of this position is to provide quality support for drug product manufacture, labeling and packaging, and distribution for clinical and commercial products at contract manufacturing organizations in the US markets.

This individual will participate in cross-functional teams with Planning, Logistics, Contract Manufacturing, Technical Development, Quality Control, Quality Assurance, Regulatory Affairs, and Drug Safety/Risk Management.

This individual will manage a small group of 2-4 direct reports.

Responsibilities include: - Develop and maintain strong relationships with contractors and corporate partners- Manage Supply Chain Quality activities at US contract manufacturing organizations (CMO) - Negotiate Quality Agreements with CMO and corporate partners- Disposition of commercial and clinical product for N.

American markets- Provide support for manufacturing deviations and investigations for drug product manufacture, labeling and packaging, drug substance and drug product shipping, and finished goods distribution- Review/approve regulatory submissions - Participate in BIIB Health Authority audits and support Health Authority audits at contract sites- Approve validation protocols and reports for drug product manufacture, supply chain shipping qualification studies, and labeling and packaging qualificationsQualificationsMinimum of 10 years Biopharmaceutical experience, with at least 5 years experience in Quality Assurance.

-Must have 5 or more years of experience managing direct reports.

-Understanding of cGMPs, quality systems and regulations.

-Excellent written and verbal communication skills.

Minimum of BS in Science or Engineering About Biogen Idec: Transforming Discovery into Care With operations across the Americas, Europe, and Asia, Biogen Idec (NASDAQ: BIIB) is one of the world's leading biotechnology companies, creating new standards of care in oncology, neurology, and immunology.

Every day, employees of Biogen Idec make a difference in people's lives, through pioneering research and development, manufacturing, and our worldwide commercial capabilities.

Learn more at www.biogenidec.com/careers .

Biogen Idec is proud to be an equal opportunity employer

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