Associate Director, R&D Quality & Compliance

The R&D Quality and Compliance Advisor provides risk-based rationale to enable decision-making and supports the development and execution of effective and comprehensive action plans to address quality and compliance risks. The Advisor consults on CAPA prioritization, development and execution with regards to major and critical audit or inspection findings. In coordination with R&D Quality and Compliance Quality Risk Management team, this role evaluates relevant metrics, proactively assesses potential risks and recommend mitigating / remediating actions to quality leads within R&D Functions. This role supports development and implementation of R&D Quality Management System (QMS) strategy, framework, methodology, infrastructure and tools, partnering significantly with other functions within R&D. On an as needed basis, the Advisor may also review and provide feedback on R&D processes and lead inspection readiness/management activities to enable R&D to be in a steady state of inspection readiness.

Key Responsibilities Include:
• Supports development and implementation of the R&D Quality and Compliance framework, methodology, tools and infrastructure
• Manages and advises on critical quality issues with senior leadership and functionally based quality leads. Evaluates and provides risk assessment to R&D Quality and Compliance leadership and Quality leads within R&D Functions regarding needs / actions
• Drives execution of R&D quality related initiatives that have a serious or high-risk impact, by utilizing a matrixed quality organization
• Participates in steering committees to provide governance and oversight of quality and compliance issues across R&D (including quality oversight of vendors)
• May provide oversight or ownership of processes and procedures as part of a R&D wide process owner network, establishing metrics and thresholds to ensure processes are achieving their goals and are in a state of quality control; will drive, execute and/or participate in process improvements, and provide support to process owners, as needed

#LI-LS1

• At least 10 years pharmaceutical or biotechnology drug development experience
• 5-6 years in a quality or compliance related discipline or equivalent quality management activities
• 5-6 years GxP QA or Compliance experience, with a strong working kno

The R&D Quality & Compliance Advisor provides global strategic leadership for quality and oversight related to Biogen R&D’s ongoing processes and programs. This role provides expertise and guidance related to relevant and current GCP/GVP/GLP (GxP) regulations, guidelines, and partners with Quality and Compliance groups within R&D functions to enable transparency & escalation of R&D quality and compliance issues.