Job TitleSr Manager, Drug Safety QualityLocationCambridge,MARequisition Number10989BRJob DescriptionThe Sr. Manager Drug Safety Quality is responsible for hiring, training and supervising Drug Safety Quality Associates responsible for internal and external auditing.

The incumbent is also responsible for ensuring departmental and contractor compliance with regulatory requirements, departmental continuous quality improvement (CQI), oversight of Drug Safety controlled documents, and coordination of global CQI/quality for Drug Safety.

The Sr. Manager is also expected to represent DSRM at interdepartmental meetings.

Essential Functions: - Manage daily activities of Quality Associates - Responsible for oversight of Drug Safety compliance initiatives- Ensure departmental compliance with corporate and departmental SOPs- Serve as safety/regulatory and quality resource for Drug Safety- Represent Drug Safety Quality on department and interdepartmental teams- Ensure departmental audit readiness- Drive controlled document creation and updates for Drug Safety, as appropriate- Review and approve all department managed documents- Maintain audit schedules for internal and external audits- Maintain documentation for and track progress of cases with potential legal issues- Track and trend departmental regulatory reporting compliance metrics and audit findings- Issue updates to the lot expiry tables to staff as appropriate- Special projects as required by management- Maintain awareness and inform company of regulatory issues impacting Drug Safetys business processes for North America and the EUAdditional Functions: - Serve as liaison between Drug Safety and the Quality organization within Biogen Idec- Manage training coordination for Drug Safety- Recruit and hire qualified quality and operations staff- Participate in Regulatory Agency inspections involving DSRMoManage training coordination for Drug SafetyoRecruit and hire qualified quality and operations staffoParticipate in Regulatory Agency inspections involving DSRMQualificationsoMust possess knowledge of GxP regulations and be able to apply them to departmental functions.

oMust be able to identify issues and gaps and apply creative solutions in a variety of situations.

oMust be able to handle multiple priorities in a rapidly changing environment.

Essential: o3 - 5 years experience in the pharmaceutical/biopharmaceutical industry in safety surveillance, regulatory affairs, quality assurance or clinical departmentsPreferred: oExperience with Pan Asian and South American regulatory requirements.

Technical Skills: oExcellent computer skills in a Microsoft environment.

oPrior experience with databases and database tools.

oWorking knowledge of US, Canadian and international regulatory requirements.

Interpersonal Skills: oMust have excellent communication skills.

oMust be able to influence/persuade others and have excellent negotiation skills.

oAbility to solve complex problems and provide creative solutions.

oProven ability to build teams and consensus and interact collaboratively in a team environment.

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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