Senior Manager, Quality Systems
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. The Kyverna therapeutic platform leverages advanced T cell engineering to suppress and eliminate autoreactive immune cells at the origin of autoimmune and inflammatory diseases. Be at the forefront of cell therapy innovation by joining scientists, industry veterans and healthcare visionaries and help transform how autoimmune diseases are treated
Reports to: Director, Quality Assurance
Location: Emeryville, CA (Hybrid – in office twice a week - Tuesday/Wednesday)
We are seeking a Senior Manager, Quality Systems to provide quality expertise to support the development and commercialization of Kyverna’s products in compliance with relevant US, EU and ICH requirements. The Senior Manager, Quality Systems will be responsible for actively managing, developing, and reporting on quality systems activities related to Deviations, Investigations, CAPAs, Change Controls, and Quality Metrics.
In addition to serving as a subject matter expert in these areas, this role will be highly collaborative across all groups in Technical Operations, Clinical, Regulatory Affairs, etc. with the overall responsibility to support the execution, development, and continuous improvement of the QMS programs at Kyverna as we grow and mature organizationally.
Responsibilities
- Manage processes and SOPs for Deviations, Investigations, CAPA, Change Control, and Quality Metrics.
- Recommend changes to policies and implement phase appropriate process improvements.
- Provide hands-on expertise and guidance in the day-to-day execution and management of QMS records in our eQMS.
- Responsible for monitoring overall quality system effectiveness and continuous improvements.
- Create and deliver training associated with QMS programs and eQMS functionality.
- Compile, evaluate, and prepare quality metrics for routine KPI reports.
- Perform trending of KPIs to assist in identifying potential risks and supporting continuous improvement.
- Adhere to all cGMPs, compliance/regulatory mandates and quality requirements.
- Build and maintain relationships with other departments and establish a culture of engagement and transparency with Quality.
- Perform other duties, as assigned.
Requirements
- Bachelor’s degree in Computer Science, Life Science or related field or applicable experience.
- A minimum of 8 years of relevant experience in the pharmaceutical/biotechnology industry with at least 6+ years in Quality Systems/Quality Assurance
- First-hand experience in managing and reviewing quality system records (e.g., deviation, CAPA, investigation, change control)
- Experience in the use of validated computer systems for management of regulated quality management system records.
- Experience with Dot Compliance, preferred.
- Experience developing improvements to electronic Quality Systems.
- Strong software proficiency with Microsoft Suite and other desktop applications.
- Ability to manage multiple projects in a dynamic environment with attention to detail.
- A well organized, self-motivated and independent work style with the ability to initiate and follow through on expected duties.
- Excellent written and verbal communication and collaboration skills with the ability to interact with all levels throughout the organization.
The salary range for this position (at Sr. Mgr.) is from $165,000 - $190,000 USD annually. This salary range is an estimate of what we reasonably expect to pay for this posted position, and the actual salary may vary based on various factors, including without limitation individual education, experience, tenure, skills and abilities, as well as internal equity and alignment with market data. This position is also eligible for bonus, benefits, and participation in Company’s stock option plan.
Kyverna is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Kyverna is committed to the principle of equal employment opportunity for all employees and does not discriminate on the basis of race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets