Sr Manager, Quality Risk Management (QRM)

Job Description

  • 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


Qualifications

  • 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




Additional Information

Biogen’s US Alzheimer’s Franchise is looking to recruit proven and ambitious sales achievers with at least five years of experience in pharma, specialty, hospital, med device/capital equipment, and/or biotech sales.
In this field-based, specialty sales representative position you will be called upon to sell our products with key stakeholders in the Alzheimer’s Disease community: including Neurologists and allied health professionals.

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