We are seeking a highly collaborative Director, Quality Assurance to join and lead the QA function for our growing organization. This strategic role will oversee all aspects of Quality, including the development, implementation, and management of GxP (cGMP, GCP, and GLP) quality systems. Our ideal candidate should have a strong knowledge of relevant regulations and be able to manage and work cross-functionally to ensure compliance of Cirsium’s ongoing development programs with local, state and federal requirements. This position will support developing a culture of quality, ensuring compliance with regulatory requirements, driving continuous improvement in quality systems, supporting the successful development, manufacturing, and commercialization of our unique products.
Assist with developing, implementing, and maintaining GxP compliant quality systems and processes to ensure compliance with FDA, EMA, ICH, and global competent authority regulations and industry guidance
Co- lead quality audits, risk assessments, and investigations, ensuring timely resolution of quality issues.
Work with the company’s external suppliers and contract organizations to ensure consistent quality and compliance.
Prepare for and manage inspections by regulatory agencies and commercial partners, serving as a liaison between the Company and auditors, including reporting and follow-up to any finding
Work on qualification and validation plans, assure proper batch releases and disposition.
Oversee resolution of any product concerns, including investigation, tracking and corrective action plans (CAPA).
Provide quality input on contracts and serve as a point person for negotiations of quality agreements.
Champion a culture of quality and continuous improvement across manufacturing and development operations.
