Associate Director, GSRS Quality at Biogen in Cambridge, Massachusetts

Posted in Information Technology 14 days ago.

Type: Full Time

Job Description:

Job DescriptionThe Associate Director, GSRS Quality, provides direct supervision to GSRS Quality Managers and/or Associates to set GSRS strategy and oversee day-to-day tasks related to GSRS compliance, audit and CAPA activities. This position will also partner with GSRS staff located at Biogen's Affiliate offices and assigned process owners within R&D to work as their quality resource to manage quality issues, process improvement opportunities and other quality related tasks. This role will collaboratively manage the GSRS audit and inspection readiness activities, for their assigned areas, and work with Pharmacovigilance subject matter experts (SME) to evaluate systems for compliance, prepare SME for audit interviewing, and create storyboards. He/She is responsible for managing the GSRS audit response process. This position will also oversee the GSRS compliance activities including metric development. This position may also be required to perform other activities within the GSRS Quality organization to achieve department objectives. He/She represents GSRS on the Quality Council, providing input on Quality risks/decisions across Global Development. Some travel maybe required.Qualifications10 years' experience in the pharmaceutical / biopharmaceutical industry, medical, or life sciences and a minimum of 4 years' experience working in a quality or quality systemsKnowledge of Post-Marketing and Clinical Trial Pharmacovigilance regulations and direct experience in GCP, GVP, or GMP regulationsStrong management skills, and ability to effectively lead and collaborate with various business functionsAbility to manage multiple, competing prioritiesDemonstrated leadership, problem solving, and conflict resolution skillsLeadership of Cross-functional initiatives/effective change management of process or technical improvements that improve department standards or practicesAbility to establish effective business relationships with external stakeholders, including implementing process changeAbility to influence without authorityExcellent written and oral communication skillsAdditional InformationAll your information will be kept confidential according to EEO guidelines.PDN-91b62b61-4479-42e2-a05f-9bbf3db3fff3