Cirsium Biosciences
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.
Generous PTO Health Insurance & Health Savings Account Vision Insurance Employee Assistance Program (EAP) Stock Options Professional Development Opportunities 401(k) Plan Life & AD&D Insurance And More... Cirsium Biosciences is an emerging company located in San Diego, California. We offer highly competitive compensation and employee programs, including comprehensive health, dental and vision plans, generous time off, and equity in our early‑stage company. We are dedicated to fostering a workplace that keeps our team inspired and engaged. We offer an inclusive company culture where employees feel respected and valued.
Cirsium Biosciences is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation, veteran status, or any other protected categories. #J-18808-Ljbffr
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.
Generous PTO Health Insurance & Health Savings Account Vision Insurance Employee Assistance Program (EAP) Stock Options Professional Development Opportunities 401(k) Plan Life & AD&D Insurance And More... Cirsium Biosciences is an emerging company located in San Diego, California. We offer highly competitive compensation and employee programs, including comprehensive health, dental and vision plans, generous time off, and equity in our early‑stage company. We are dedicated to fostering a workplace that keeps our team inspired and engaged. We offer an inclusive company culture where employees feel respected and valued.
Cirsium Biosciences is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation, veteran status, or any other protected categories. #J-18808-Ljbffr