Sr Manager, Quality Assurance & Governance

Role Summary

The Senior Manager in 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 RD&M stakeholders. The role directly supports the RD&M GxP Audit Program, 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 internal and external audits. It also drives a culture of quality and compliance across RD&M, contributes to cross-functional quality improvement initiatives, and assists with inspections.

Responsibilities

• 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.

Qualifications

• Required: Bachelor's Degree in a scientific field.
• Required: 5+ years’ experience in the pharmaceutical/biotechnology industry with 5+ years of GVP, GCP, GLP/GCLP operations and/or quality and compliance experience.
• Preferred: Direct experience with Good Practice (GxP) guidelines, compliance quality systems, and PV knowledge.
• Required: Experience in audits, inspection management, inspection readiness, CAPA management, quality risk management or related quality management system responsibilities.
• Required: Working knowledge and understanding of the GxP regulations including USA (FDA), EU (EMA and MHRA), Japan (PMDA), ICH Guidelines and general compliance.
• Required: Detail oriented and quality mindset; ability to work in a team environment and set priorities appropriately.
• Required: Strong understanding of GVP, GCP, GCLP/GLP and/or audit processes in the biotech, pharmaceutical, and/or CRO industry.
• Required: Strong time management, project management, organizational, communication and interpersonal skills.
• Preferred: Audit database and database query experience, desired.
• Required: Excellent written and verbal communication skills, including strong ability to facilitate meetings/discussions, and ability to collaboratively partner with cross-functional area colleagues.
• Required: Experience leading or executing some or all quality activities including but not limited to audit, inspection, controlled documentation, deviations, quality issues, training, vendor management, and quality risk management.
• Required: Ability to identify areas for process improvement and lead discussions to implement change.