Director, Quality Compliance and Risk Management

Employer
Kyverna Therapeutics, Inc.
Location
Emeryville, California
Salary
Negotiable
Posted
Apr 01, 2024
Closes
Apr 08, 2024
Ref
2740635944
Position Type
Director
Hours
Full Time
Work Mode
On-site
Employment Type
Contract
Organization Type
Corporation / LLC, Private Practice
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
Responsibilities:
  • Utilize advanced, international GxP expertise and management experience to develop, execute, and optimize cost effective, risk-based, quality assurance and compliance programs.
  • Develop and implement a strategic vision for GxP Quality System maturity to align with business (and regulatory) objectives. Design and build the Quality inspection readiness cross functional teams.
  • Drive the execution of a scalable and risk-based quality assurance and compliance infrastructure related to risk management of operations and quality system maturity and compliance.
  • Develop and maintain the GxP supplier assessment strategy and plan in collaboration with program/study teams and in line with program timing and objectives. Perform contract service provider evaluations, as required.
  • Collaborate with cross-functional teams to address risks and implement corrective and preventive actions.
  • Implement Inspection Readiness program and act as inspection and lead provide leadership for inspection readiness training and preparation for mock interview/audits. Participate in regulatory agency inspections.
  • Plan/strategize inspection readiness activities to support program/study team.
  • Establish a quality roadmap to support development goals including developing and implementing policies, procedures, and processes that align with industry best practices and regulatory requirements. Continuously evaluate and enhance the quality systems to drive efficiency and compliance.
  • Support investigations into critical quality issues and product complaints. Facilitate identification of root cause, and development of appropriate corrective and preventive actions.
  • Suggest the development, implementation, and maintenance of quality systems, processes, and procedures related to GxP operations to mitigate compliance risks identified.
  • Recruit, train, and mentor a high-performing team of quality assurance professionals.
  • Foster close collaboration with manufacturing, regulatory affairs, clinical operations, and other departments to ensure alignment and coordination in quality compliance activities. Provide guidance and support to these teams on quality-related matters.
  • Maintain expert up-to-date knowledge on legislation and relevant parts of GxP guidelines, requirements and practices and ensure that the information is communicated through the organization and integrated into the Quality and Operating processes within Kyverna and the organizations supporting clinical development.
  • Other duties as assigned.
Requirements:
  • Advanced degree in life sciences, pharmacy, or a related field.
  • Minimum of 10 years of experience in GxP compliance and monitoring within the biotechnology or pharmaceutical industry, with a focus on autologous and allogeneic cell therapy treatments preferred.
  • Strong knowledge of applicable regulatory requirements, including FDA and EMA regulations and ICH guidelines, with an emphasis on requirements associated with the study of cells and tissues, particularly genetically modified cells as therapies.
  • Proven track record in developing and implementing quality systems and processes throughout the product and clinical lifecycle.
  • Successful management of audits and inspections by regulatory agencies.
  • Excellent verbal, written and presentation skills to effectively communicate with all levels of management.
  • Demonstrated expertise in critical thinking, influence, negotiation, problem solving, strategic thinking and leadership in a matrix environment.
  • Demonstrated strong leadership capability with ability to make and act on decisions while balancing speed, quality, and risk.
  • Excellent leadership skills with the ability to influence and collaborate effectively across cross-functional teams.
  • Strong analytical and problem-solving skills, with a focus on risk management and continuous improvement.
  • Demonstrated ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives.
  • Ability to work in a matrix environment and build strong relationships by being transparent, reliable, and delivering on commitments.
  • Self-starter, works effectively in teams.
$190,000 - $240,000 a year
The 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