Senior Manager, Computerized Systems Quality Assurance
Emeryville, CA
Quality /
Full Time /
On-site
Kyverna is recruiting a highly motivated Senior Manager of Computer Software Assurance (Computer System Validation) in its Quality organization to help advance its mission to free patients from the siege of autoimmune disease. The ideal candidate will build and lead a Software Quality Assurance (CSA) program focusing on GAMP 5 and Health Authority (Part 11 and Annex 11) compliance for systems wholly managed by Kyverna as well as assessing and communicating risks associated with the the compliance of systems managed by Kyverna contract service providers (CSP) and partners. Adherence to phase appropriate regulatory requirements, enhancing quality compliance, and maintaining the highest standards of quality in CSA for technical, clinical, and regulatory operations is the mission of this role.
The Senior Manager will be responsible for creating and executing a CSA program for Kyverna including quality management elements (SOPs and policies), lifecycle management (validation, change management, risk assessment), and assessing the compliance of computerized systems utilized by Kyverna CSPs in support of clinical operations, manufacturing, and regulatory systems. The role will report to the Head of GxP Quality.
Responsibilities:
- In collaboration with Quality, Technical Operations, Regulatory Affairs, Clinical Operations, and Finance support automation (Veeva, SAP, logistics), document management (Veeva Vault, Veeva RIMS), and learning management (ComplianceWire) strategies for Kyverna’s operations including qualification, validation, and lifecycle management support.
- Develop and maintain Kyverna’s CSA program, including establishment of protocols, lifecycle management, and CSP audit support.
- Manage Validation/Qualification of systems as needed, to support multi-phase clinical trials.
- Provide subject matter expertise in the investigation of computerized system quality events.
- Support operations to develop and monitor key performance indicators and risk management to ensure effective and efficient processes, compliant system utilization, and oversight of Kyverna’s systems.
- Ensure computerized system issues are identified and managed through to resolution in a timely manner and support the administration of these systems.
- Work with functional leadership to design, implement and maintain phase appropriate levels of automation in support of Kyverna’s programs.
- Support business development due diligence projects as needed to support analysis and assessment of internal/external laboratory capabilities.
- Other duties as assigned.
Requirements:
- Degree (bachelor's or higher) or equivalent experience in life sciences, or computer sciences., or related field.
- 8+ years of pharmaceutical manufacturing and/or Quality Assurance experience, with at least 2 years' experience with computer systems validation.
- Experience implementing systems compliant with GAMP 5, Annex 11, or Part 11.
- Demonstrated ability to manage contract resources supporting CSV, including authoring of validation master plans and protocols, training against protocols, and writing summary reports.
- Deep knowledge and experience with one or more of the leading lifecycle quality management, regulatory information, or ERP systems is required.
- Ability to think critically, and demonstrated troubleshooting, problem-solving, and risk assessment skills.
- Strategic thinking and high emotional intelligence.
- Excellent interpersonal, verbal, and written communication skills.
- Ability to function efficiently and independently in a changing environment.
- Manage and advance multiple projects simultaneously and dynamically reprioritize as needed.
- Demonstrated capacity to think creatively when addressing complex situations.
- Ability to communicate effectively with Kyverna Leadership, clinical, biomarker, biostatistical, and pre-clinical scientists, and with external business partners and Regulatory Authorities.
$140,000 - $155,000 a year
The salary range for this position is from $140,000 - $155,000 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.
