Risk Management Director manages and administers an organization's risk-management programs. Implements policies, procedures, and controls to monitor and minimize the risk exposure of assets. Being a Risk Management Director researches internal and external risk factors including economic, market, and regulatory risks that may affect the organization. Routinely evaluates the effectiveness of procedures and collaborates with internal stakeholders to monitor changes in the business environment. Additionally, Risk Management Director manages statistical analysis and designing of financial models to predict the risk exposure of an organization's assets. Reviews risk analysis reports to ensure risks are identified and managed effectively. Requires a bachelor's degree. Typically reports to a director. The Risk Management Director typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Risk Management Director typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (Copyright 2024 Salary.com)
Kyverna Therapeutics is a clinical-stage cell therapy company with the mission of engineering a new class of therapies for autoimmune diseases. The Kyverna therapeutic platform combines advanced T cell engineering and synthetic biology technologies to suppress and eliminate the 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.
Kyverna is recruiting a highly motivated Director of Quality Quality Compliance and Risk Management to establish and lead our quality system maturity efforts efforts and advance our mission to free patients from the siege of autoimmune disease. As a Leader in the Quality Function, this individual will help build and lead a Quality Unit focusing on assessing and communicating risks in the GxP operations and inspection readiness including processes for risk and knowledge management supporting the advancement of our clinical development programs both in the US and internationally. Adherence to regulatory requirements, enhancing quality compliance, and maintaining the highest standards of quality in GxP operations is the mission of this role.
This position will collaborate with internal technical operations, clinical operations, and regulatory affairs functions and external parties including consultants, contract auditors, and contract service providers to promote a high level of quality and consistency across and within programs; develop the risk-based audit and compliance strategy for all programs. Additionally, this position will independently manage domestic and international risk-based audits and assessments of internal and external operations with the goal of continuous improvement and maturation of the Quality Management System at Kyverna and across Kyverna suppliers and partners. Company policies and procedures; data integrity, and business operations. The Director will support a culture of sustainable compliance; assist project teams in implementing corrective and preventive actions; and enable teams to be inspection ready.
The ideal candidate will have deep experience in GxP Quality and heath authority inspections of biopharmaceutical products with additional experience in products involving genetically modified cell therapies. They will contribute to our goals while living our core values: Bring Intellectual Rigor, Elevate Each Other, and Stay True to Why.
If you are passionate about transforming the lives of patients and making significant contributions to the field of cell therapy, we invite you to join us; and together we can drive forward innovative treatments and improve the standard of care to tame autoimmune diseases
\nThe salary range for this position is from $190,000 - $240,000 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
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