About the Role:

As the Associate Director, R&D Quality and Compliance you play an essential role within Biogen’s quality team. You provide expertise and leadership for compliance and quality activities specifically within the Clinical Development function. This position is responsible for driving a culture of quality and overseeing compliance within the function and will serve as an advocate for the Quality Management System (QMS). As a Functional Quality Representative (FQR), you will liaise with the R&D Quality and Compliance team and FQRs from other R&D functions and operate within the defined quality governance structure.

This role will report to the Head, R&D Quality Culture, Process and Systems with a dotted reporting line to the Head, Therapeutics Development Unit.

*The role will require one week per quarter onsite in Cambridge.

What You’ll Do:

Drive a culture of quality within the Clinical Development Units

·       Educate Medical Directors about the R&D QMS and relevant regulations and best practices​​

·       Interpret, analyze, and integrate new and updated regulations and guidance documents​

·       Communicate quality and compliance risks to leadership​

Provide quality support to Clinical Development with activities such as audits, inspections, vendor management and CAPAs.

·       Lead investigation and Root Cause Analysis of quality issues​

·       Manage and provide quality approval of CAPA Plans and Effectiveness Checks​​

·       Conduct inspection preparation, coordinate inspection activities, facilitate the creation of inspection finding responses​

·       Assist with Audit planning and manage Audit responses​

·       Support sub-process owners in revision of existing processes or development of new processes. Review and approve controlled documents and process deviations​

·       Support staff with the use of computer systems for managing quality processes

·       Lead or assist with vendor selection, qualification, and oversight activities ​

Assess risks and issues and guide staff to take a risk-based approach to quality​

·       Serve as a point of contact for quality questions from staff and management​

·       Perform Quality Impact Assessments of Quality Issues​

·       Identify and monitor metrics to assess the quality health of a functional area and/or process; assist with mitigation plans and continuous improvement ​

·       Facilitate and oversee Quality Risk Management (identification, analysis, evaluation, mitigation, measurement, and reporting of risks)

Who You Are:

You are passionate about Quality and enjoy educating and helping teams to see the value it brings to their work.

Required Skills:

·       In-depth understanding of global and local Good Clinical Practice (GCP) regulations and industry best practices

·       Experience leading or executing some or all quality activities including but not limited to Audit, Inspection, Vendor Management, Controlled Documentation, Deviations, Training, Quality Risk Management and Regulatory Intelligence.

·       Demonstrated technical understanding of computer systems for managing quality processes

·       Ability to influence without authority, successfully implement change management and lead others through change

·       High attention to detail including proven ability to manage multiple, competing priorities and to prioritize appropriately

·       Excellent negotiation and problem-solving skills

·       Bachelor’s Degree required, Masters/PhD optional – Life Sciences, Regulatory Science, Regulatory Compliance, or Drug Development preferred

·       8 - 10 years pharmaceutical or biotechnology drug development experience including 5-8 years GxP QA or Compliance experienced

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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.