The Senior Manager role within Quality Assurance & Governance (QAG) serves as a Research and Development Quality and Compliance (RDQC) representative providing expert auditing, inspection support and quality governance support to Biogen Research, Development and Medical (RD&M) stakeholders. The position directly supports the RD&M GxP Audit Program by contributing to planning, conduct, approval and close-out of audits, and supporting GxP/GVP audit strategy, risk assessment and annual audit planning using a risk-based approach for selection of internal and external audits. Additionally, they will have responsibility for implementing a culture of quality and compliance across RD&M, contributing to cross-functional quality improvement initiatives and support of inspections.

What You’ll Do

• Provides input into the GxP/GVP annual audit strategy, risk assessment and annual audit plan.

• Facilitate the planning, conduct, approval, and close-out of audits performed by qualified auditors.

• Collaborate with internal and external stakeholders to obtain key audit information and documents in support of audit planning and researching the audit area to develop appropriate audit scope.

• Facilitate pre-audit and audit debrief meetings with key stakeholders

• Oversee the execution of the end-to-end audit processes to ensure the coordination and execution of audit scope and follow-up activities with relevant stakeholders.

• Lead and participate in audit process improvement initiatives.

• Develop and perform quality review of documentation in support of audit management.

• Participate in functional and cross-functional quality process improvement initiatives.

• Support investigations, root cause analysis and implementation of actions for relevant quality issues, CAPAs or Effectiveness Checks.

• Support inspection readiness, preparation and execution activities.

Who You Are

You are a detail-oriented quality professional with expertise in GxP (GVP, GCP, GCLP/GLP) auditing and regulatory compliance within the pharmaceutical, biotech, or CRO industry. You bring strong project management, communication, and leadership skills to effectively plan and execute audits, support inspections, and drive cross-functional quality initiatives. You foster a culture of quality and continuous improvement while serving as a trusted partner to R&D and Medical stakeholders.

Required Skills

• Bachelor’s Degree required in scientific field.

• 5+ years’ experience in pharmaceutical/biotechnology industry with 5+ years of GVP, GCP, GLP/GCLP operations and/or quality and compliance experience.

• Direct experience with Good Practice (GxP) guidelines, compliance quality systems, and PV knowledge.

• Detail oriented and quality mindset; ability to work in a team environment and set priorities appropriately.

• Strong understanding of GVP, GCP, GCLP/GLP and / or audit processes in the biotech, pharmaceutical, and/or CRO industry.

• Strong time management, project management, organizational, communication and interpersonal skills.

• Strong computer / technical skills. Proficient in Microsoft Office Suite (Word, Excel, PowerPoint) and MS Outlook. Audit database and database query experience, desired.

• Excellent written and verbal communication skills, including strong ability to facilitate meetings/discussions, and ability to collaboratively partner with cross-functional area colleagues.

Preferred Skills