Manager, Clinical Operations Quality Oversight

at  Biogen

Company Description
At Biogen, we pioneer in advancing science and strive to drive results whilst effectively managing risk. We are humble and curious and work towards creating a culture of integrity, trust, and treat everyone with openness, care, and dignity. The role of Manager in the Quality Systems & Technology team is aimed to provide quality oversight for computerized systems, technology, and solutions in accordance with GCP and applicable global regulations and Biogen policies and procedures. You will advocate for a risk-based approach to quality management, assess and manage risks as they emerge, and help drive efficiency while also ensuring compliance. You will be expected to build/enhance knowledge of regulatory trends and provide guidance to internal teams relating to the emerging regulations. An understanding of computer system validation and associated regulations combined with competencies in cross collaboration with R&D Quality & Compliance (RDQC), functional leads and IT operations is required.
Job Description

REQUIRED SKILLS

• Bachelor’s Degree required. Master’s or Advanced Degree preferred.
• 5-7 years of Clinical Trial/compliance/quality experience working in the biotechnology or pharmaceutical industry.
• Experience with regulatory inspections.
• Experience with Quality Management Systems.
• Must demonstrate extensive knowledge of the principles GCP regulations including data integrity requirements, computer system validation, GAMP 5, medical devices regulations etc.
  Additional Information

• Supporting quality oversight of computer systems and emerging technologies.
• Participating in process improvements and functional initiatives, as required.
• Overseeing and approving CAPAs / Effectiveness checks.
• Understanding of quality by design, risk assessments, quality measures and metrics.
• Understanding of the principles of data integrity.
• Supporting and engaging in cross-functional initiatives and ensuring timely execution of defined goals/objectives, including anticipating and identifying project risks, mitigations, and contingencies.
• Supporting audits and inspections. Supporting closure of regulatory agency commitments and CAPAs specific to systems and technology.
  Qualifications