Executive Director, Analytical Development & Quality Control

Ardelyx is a commercial-stage biopharmaceutical company seeking an Executive Director, Analytical Development & Quality Control. The successful candidate will provide strategic roadmap for the AD/QC department, aligning it with the overall company objectives and regulatory requirements.

Requirements

• Provide strategic roadmap for the AD/QC department
• Partner with other functions to develop and implement appropriate control strategies
• Lead and collaborate with other departments to implement quality and process improvement initiatives
• Oversee the development, validation, implementation, and life-cycle management of analytical methods
• Ensure AD/QC activities are conducted in accordance with current Good Manufacturing Practices (cGMPs) and relevant regulatory requirements
• Author and review IND/NDA Module 3 sections
• Manage and develop a team of skilled professionals
• Develop and maintain productive relationships with outsourced analytical testing partners
• Allocate internal and external resources effectively
• Develop and monitor Key Performance Indicators (KPIs) for the AD/QC department
• Collaborate with QA in the preparation and presentation of reports to management

Benefits

• 401(k) plan with generous employer match
• 12 weeks of paid parental leave
• Up to 12 weeks of living organ and bone marrow leave
• Equity incentive plans
• Health plans (medical, prescription drug, dental, and vision)
• Life insurance and disability
• Flexible time off
• Annual Winter Holiday shut down
• At least 11 paid holidays