Associate Director of QA Computer Systems

Responsibilities

• Participate in the planning, execution, and oversight of the full computer system lifecycle to ensure compliance with GxP regulations
• Work across multiple departments, including QA, Clinical, De-commerce, IT, Finance, and with vendors to ensure computer systems meet business and regulatory needs
• Support the ongoing and dynamic needs of the QA Computer Systems processes as the company transitions from the clinical to the commercial phase
• Maintain the validated state of the QA Computer Systems, including validation documentation, system documentation, periodic reviews, project management, and inspection support

Requirements

• Extensive experience in the pharmaceutical industry
• Experience working with cloud-based Computer Systems/Computer Systems Validation
• Knowledge of GxP regulations

About the Company

Rezolute is a late-stage rare disease biopharmaceutical company focused on developing transformative therapies for patients living with severe metabolic and endocrine disorders. Our mission is to bring hope and meaningful solutions to patients and families affected by rare and difficult-to-treat diseases through scientific innovation, collaboration, and integrity.