Head of R&D Quality and Compliance

About This Role:

As the Head of R&D Quality and Compliance you will be responsible for Biogen’s Research and Development Quality Management System (QMS) strategy and execution globally including quality risk management, quality culture and processes, and quality data and analytics. This includes quality and compliance elements covering Good Clinical Practice (GCP) and Good Laboratory Practice (GLP), Good Research Practice (GRP) and Good Pharmacovigilance Practice (GVP).

What You’ll Do:

• Provides global strategic leadership for R&D Quality and Compliance (RDQC) to ensure governance and oversight of R&D’s Quality Assurance processes (i.e. audit strategy/execution, inspection readiness/execution, etc.), assessment of complex quality/compliance issues/risks, evaluation & reporting framework of quality and compliance risks to executive leadership.
• Sets vision for R&D Quality & Compliance team driving value through a risk-based, proactive & preventative approach to quality.
• Accountable for R&D Quality & Compliance workload and resource management, including annual budget management
• Provides the strategic direction for quality leadership (R&D and Medical) in a matrixed/cross functional environment, collaborating to address roadblocks, challenges, resourcing constraints and prioritization of challenges related to R&D Quality and the R&D QMS.
• Chairs select QMS governance boards and quality forums, and drives an aligned escalation of QMS health to senior management and governance boards.
• Develops and oversees framework for the R&D QMS; defines and monitors measurable quality objectives with functions executing R&D activities
• Partners with Quality and Compliance organizations across Biogen to enable transparency & escalation of R&D quality and compliance issues as well as supports non GXP quality and compliance efforts that impact R&D.
• Sets risk evaluation strategy and framework on compliance and quality issues with senior leadership which includes enterprise-level R&D metrics and associated standards.

Who You Are:

In addition to having excellent written and communication skills, you successfully worked in a matrix environment demonstrating ability to collaborate and influence. You have proven experience with overseeing and setting a strategic direction for a quality management system and driving execution, leading change and cultivating networks. You have robust global, health authority experience (inspections/other interactions) and have a strong understanding of regulations across GCP, GVP, GRP and GLP

Required Skills:

• At least 12 years pharmaceutical or biotechnology drug development experience;
• 8 years in a quality or compliance related discipline or equivalent quality management activities;
• 8 years GXP QA or Compliance experience, with strong GVP and GCP experience and experience in multiple disciplines.
• 8 years of people management (including senior level positions)
• Working knowledge of international GXP regulations and directives, including USA (FDA), EU (EMA), UK (MHRA), Japan (PMDA) and ICH Guidelines.
• Strong strategic, critical thinking skills with ability to influence senior leadership and ability to manage multiple complex projects simultaneously

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Why Biogen?

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.

• Type: Full-time
• Function: Quality Assurance