Amgen Commercial Program Quality Oversight Manager (Compliance Manager) in Thousand Oaks, California
The Commercial Program Quality Oversight Manager role is a global role and reports to the Director, Quality Strategy and Governance within Amgen's R&D Quality, Compliance & Audit organization.
This role will be based at Amgen's Thousand Oaks site. Key Responsibilities:
Act as key interface with Commercial, Safety and other functions for all the Commercial Program Quality Oversight Team activities.
Apply a risk based approach to Patient Support Program (PSP) vendor monitoring / data reviews Interface with data privacy to determine acceptable records for review.
Gather information about the PSP and data availability to conduct an initial monitoring visit. Conduct monitoring visits to review records for safety reporting requirements (Ability to travel up to 25%).
Perform quarterly data reviews on the selected PSP programs.
Conduct quarterly quality evaluations of the PSP and Market Research repositories.
Evaluate and approve Commercial Program purchase orders to ensure safety reporting requirement are incorporated.
Review, revise and maintain business processes, process documentation/tools, and training for safety reporting requirements and vendor engagement of commercial programs.
Manage the R&D CAPA System (RDCS) items assigned to the Commercial Program Quality Oversight Team and act as the responsible person/BPO delegate to progress assigned exceptions through RDCS Present significant issues and proposed solutions to the Safety Compliance Committee
Maintain Sharepoint site / team repository.
Support activities to improve the R&D Quality Management System (QMS)
May represent Quality and the R&D QMS in Merger & Acquisition activities.
Master's Degree and 3 years of Quality, Compliance, Audit, and/or Safety experience
Bachelor's Degree and 5 years of Quality, Compliance, Audit, and/or Safety experience
Associate's degree and 10 years of Quality, Compliance, Audit, and/or Safety experience
High school diploma/GED and 12 years of Quality, Compliance, Audit, and/or Safety experience
Bachelor's Degree 4+ years in Clinical Quality, PV or GCP Compliance, Safety or other relevant area of pharmaceutical/biotech industry such as Study Management
Pharmacovigilance and /or Audit experience
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.