Manager, Drug Safety Quality

Job Description The Manager of Drug Safety Quality is responsible for the daily management of the Drug Safety Associates in their role as internal/external auditors. In this role, the incumbant will be responsible for hiring and training of auditing personnel, will conduct internal and external audits, will maintain departmental continuous quality improvement initiatives, will serve as the safety/regulatory and quality resource for Drug Safety, will represent the department on interdepartmental teams, and will serve as the liaison between Drug Safety and the Corporate Quality organization within Biogen Idec.

Qualifications
Five or more years experience in the pharmaceutical industry in safety surveillance, regulatory affairs, quality assurance or clinical research with proven management capability is required. Candidates must possess thorough knowledge of GxP regulations (with proven experience in a GCP regulated environment) and be able to apply them to departmental functions, must be able to identify issues and gaps and apply creative solutions in a variety of situations, must be able to handle multiple priorities in a rapidly changing environnment.

Education
A Master's level degree in the medical or life sciences, regulatory affairs, or other pharmaceutical area, or the equivalent experience.