Senior Manager, GCP Quality Assurance & Governance

Summary

Join Biogen as a Senior Manager, GCP Quality Assurance & Governance in R&D Quality and Compliance, providing global strategic leadership for quality oversight in clinical research and development. You will support the GCP annual audit strategy, lead audits, manage quality risks, and develop and maintain R&D audit infrastructure. Responsibilities include providing regulatory expertise, supporting the R&D Quality Management System, and chairing quality governance forums. The role requires a Bachelor's degree, 5+ years of auditing experience in GCP, and 8+ years of pharmaceutical/biotechnology experience. Biogen offers a competitive salary, LTI grants, and a comprehensive benefits package.

Requirements

• Bachelor’s degree required
• 5+ years of auditing experience in GCP required
• 8+ years pharmaceutical or biotechnology drug development experience within Quality Compliance, including strong GCP experience, required
• Must be flexible and comfortable with a risk-based approach to quality and ownership of quality across functional lines
• Working knowledge of international GxP regulations, including USA (FDA), EU (EU Clinical Trial Directive 2001/20/EC and Regulation 536/2014), Japan (PMDA) and ICH Guidelines
• Strong strategic, critical thinking skills with ability to influence senior leadership as well as Legal, Global Medical, Corporate Compliance, and IT
• Excellent communication skills, verbal, written and presenting in English as well as diplomacy, cross cultural and team skills
• Working knowledge of MS Word, Excel, PowerPoint, SharePoint, Outlook, and audit management systems
• Ability to manage multiple projects simultaneously, prioritize workload for teams and function in fast paced environment as typically demonstrated during health authority inspections
• Ability to travel 20% of time required

Responsibilities

• Support the GCP annual audit strategy by functioning as a Lead Auditor in GCP audits of vendors, internal processes and investigator sites which includes managing the scheduling, planning, conducting, approval, response and close-out of the audit
• Maintain holistic oversight of quality risk. This includes identifying quality risks from a spectrum of available resources; escalating risks as appropriate to drive resolution; providing risk-based rationale to enable decision-making; managing or supporting the development and execution of effective and comprehensive corrective and preventative action (CAPA) plans to address quality and compliance risks; consulting and advising on CAPA prioritization, development and execution with regards to major and critical audit findings, inspection findings and quality issues; overseeing relevant quality metrics especially those relating to inspections; proactively assessing potential quality risks and recommends mitigating / remediating actions to quality leads within R&D functions
• Assist in the development and maintenance of the R&D Audit infrastructure, including audit risk assessment and the Annual Audit Plan, together with oversight of end-to-end audit conduct by audit functional service providers, as needed
• Provide expertise, interpretation and guidance related to relevant and current regulations, guidelines, and industry standards to drive compliance across R&D and prepare study teams for upcoming health authority inspections
• Support development and implementation of the R&D Quality Management System strategy, framework, methodology, infrastructure, core quality management processes and tools
• Attend and chair relevant quality governance forums, including risk councils, as needed
• Function as Lead Auditor in GCP audits of vendors, internal processes, and investigator sites, including managing the scheduling, planning, conduct, approval, response and close-out of the audit
• Provide subject matter expertise in the development and review of procedural documents related to the audits, CAPA, and observational trend analysis
• Support sponsor inspection readiness preparations, inspection conduct, response generation, and adherence to inspection CAPA commitments

Preferred Qualifications

Masters or PhD in Biology / Chemistry, Life Sciences, Regulatory Science, Regulatory Compliance, or Drug Development preferred

Benefits

• LTI grants
• Other incentive programs
• Medical, dental, life, long and short-term disability insurances
• Vacation
• End-of-year shutdown
• 401K participation and matching contributions