Vacancy caducado!
Job Description
The Associate Director, GSRS Quality, Head of Affiliate Oversight, will build a team of quality professionals to support the R&D QMS in Biogen’s global network of 29+ Affiliate Offices. This will include Global Safety and Regulatory Sciences (GSRS) functions at the affiliates. This role will provide direct supervision to their team of GSRS Quality Managers and/or Associates to set strategy and oversee day-to-day tasks related to compliance, audit and CAPA activities. This position will also partner with local leaderships at 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.
Qualifications
10 years’ experience in the pharmaceutical / biopharmaceutical industry, medical, or life sciences and a minimum of 4 years’ experience working in a quality or quality systems
Knowledge of Post-Marketing and Clinical Trial Pharmacovigilance regulations and direct experience in GCP, GVP, or GMP regulations
Strong management skills, and ability to effectively lead and collaborate with various business functions
Ability to manage multiple, competing priorities
Demonstrated leadership, problem solving, and conflict resolution skills
Leadership of Cross-functional initiatives/effective change management of process or technical improvements that improve department standards or practices
Ability to establish effective business relationships with external stakeholders, including implementing process change
Ability to influence without authority
Excellent written and oral communication skills
Additional Information
All your information will be kept confidential according to EEO guidelines.
Vacancy caducado!