Cirsium Biosciences is creating the next generation of manufacturing technologies for viral vector production. Our novel plant-based platform solves the existing problems of speed, flexibility, scalability, and safety in viral vector manufacturing while dramatically reducing production costs. Our goal is to enable global and equitable access to life-changing genetic therapies.

Position Overview

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.

Key responsibilities

• 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.

Qualifications

• Bachelor’s degree in biological sciences or related field, with a minimum of 7 or more years experience in Quality Assurance or related fields within the pharmaceutical or biotechnology industry
• Extensive knowledge of GxP (GMP, GLP, and GCP) regulations and guidelines, including FDA, EMA, and ICH requirements
• Demonstrated hands-on experience working on complex projects.
• In-depth knowledge of FDA, EMA, and ICH guidelines, regulations, and processes related to CMC.
• Strong partnering and communication skills required, as well as project management skills.
• Must be focused on working collaboratively and within our values of: Data rules, All-in, Own it (Accountable), Caring and Humble.
• Ability to work effectively in a collaborative, fast-paced environment.
• Strong analytical skills, excellent problem-solving skills, and innovative thinking for sustainable practices.
• Strong organizational and time-management skills with the ability to handle multiple projects.
• Excellent leadership and communication skills, and the ability to work in a collaborative, fast-paced environment.