About This Role

The Associate Director Research & Development Quality and Compliance team provides expertise and leadership for GxP compliance and quality activities across the entire Quality and Strategic Operations (QSO) department. The Associate Director will address quality and compliance requests and questions, ensure inspection readiness, and provide quality and compliance guidance to the department. This role will also provide leadership and expertise to support the quality assurance processes in QSO, which include quality risk management, issue management,  inspections, vendor management, and document management.

What You’ll Do

• Assess risks and issues and guide staff to take a risk-based approach to quality​
• Educate team members on the R&D QMS and relevant regulations and best practices​​
• Interpret, analyze and integrate new and updated regulations and guidance documents
• Lead investigation and Root Cause Analysis of quality issues​ and assist with Audit planning and managing Audit responses
• Manage and approve CAPA Plans and Effectiveness Checks​​
• Conduct inspection preparation, coordinate inspection activities, facilitate the creation of inspection finding responses​

Who You Are

• You have a strong knowledge of GxP regulations and industry best practices. Ability to drive a culture of quality within the QSO department. Have excellent attention to detail, including proven ability to manage multiple competing priorities and prioritize appropriately.

#LI-DR1

Required Skills

• Bachelor’s Degree in Life Sciences, Regulatory Science, Regulatory Compliance, Drug Development, or related field. Masters/Ph.D. preferred
• 8 - 10 years pharmaceutical or biotechnology drug development experience including 5-8 years GxP, Quality Assurance, or Compliance experience
• Must have demonstrated knowledge of GxP regulations and industry best practices
• Demonstrated technical understanding of computer systems for managing Quality processes
• Ability to successfully implement change management and lead others through change
• Experience leading or executing some or all Quality activities, including but not limited to Audit, Inspection, Vendor Management, Controlled Documentation, Quality Risk Management, and Regulatory Intelligence

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.

All your information will be kept confidential according to EEO guidelines.