Massachusetts Veterans Jobs

MassHire JobQuest Logo

Job Information

Biogen Sr Manager, Quality Risk Management (QRM) in Cambridge, Massachusetts

  • Supports the GCP and GLP Quality Risk Management Advisors in providing oversight for GCP and GLP across Biogen R&D, identifying, assessing, advising on and overseeing mitigation of impactful quality risks, providing input into R&D Quality & Strategic Operations (QSO) leadership and functional quality leads. * Support the GCP/GLP Audit Program for R&D, including but not limited to GCP/GLP Global Affiliate Audits, GCP/GLP Vendor Audits, and GCP/GLP Internal Process/QMS Audits * Supports the conduct of quality risk management activities at the process level across R&D * Supports the execution of a regulatory intelligence process for R&D * Supports the execution of proactive inspection readiness to create a state of inspection readiness across study teams * Manages and oversees sponsor inspection readiness preparations, inspection conduct, response and adherence to inspection CAPA commitments * 6-8 years pharmaceutical or biotechnology drug development experience * 5-6 years preforming quality or compliance related tasks * 5-6 years of GCP and/or GLP experience * Working knowledge of MS Office programs, Sharepoint, and audit management systems * Ability to manage multiple projects simultaneously, prioritize workload for teams and function in a fast paced environment Education: * Bachelor’s degree required, Masters or PhD in biology / chemistry, Life Sciences, Regulatory Science, Regulatory Compliance, or Drug Development preferred All your information will be kept confidential according to EEO guidelines.