Biogen

Associate Director, Quality Assurance & Governance


PayCompetitive
LocationRemote
Employment typeFull-Time

This job is now closed

  • Job Description

      Req#: REQ19580
      Employer Industry: Biotechnology

      Why consider this job opportunity:
      - Salary up to $237,000
      - Eligible for participation in the employer's long-term incentive grants and other incentive programs
      - Comprehensive benefits package including medical, dental, life, and disability insurances
      - Opportunities for professional development and growth within a mid-sized company
      - Collaborative work environment with a commitment to excellence and innovation

      What to Expect (Job Responsibilities):
      - Ensure quality oversight of regulatory health authority inspections and develop an inspection management framework
      - Drive resolution of regulatory inspection findings and report them in a timely manner
      - Lead the development and maintenance of the R&D Audit infrastructure, including audit risk assessments
      - Oversee process refinement efforts and execution of quality management processes
      - Monitor relevant quality metrics and recommend actions to mitigate potential quality risks

      What is Required (Qualifications):
      - Bachelor’s degree required
      - 8+ years of clinical trial experience in the biotechnology or pharmaceutical industry; experience with CROs is highly desirable
      - Experience with regulatory inspections and audits
      - Proficient in Quality Management Systems
      - Extensive knowledge of GCP regulations, including data integrity requirements

      How to Stand Out (Preferred Qualifications):
      - Master's or PhD in Biology, Chemistry, Life Sciences, Regulatory Science, Regulatory Compliance, or Drug Development

      #Biotechnology #QualityManagement #ClinicalTrials #CareerGrowth #DiversityAndInclusion

      We prioritize candidate privacy and champion equal-opportunity employment. Central to our mission is our partnership with companies that share this commitment. We aim to foster a fair, transparent, and secure hiring environment for all. If you encounter any employer not adhering to these principles, please bring it to our attention immediately.
      We are not the EOR (Employer of Record) for this position. Our role in this specific opportunity is to connect outstanding candidates with a top-tier employer.
  • About the company

      Biogen Inc. is an American multinational biotechnology company based in Cambridge, Massachusetts, specializing in the discovery, development, and delivery of therapies for the treatment of neurological diseases to patients worldwide.

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