Senior Manager, Computerized Systems Quality Assurance
Kyverna
- Emeryville, CA
- $140,000-155,000 per year
- Permanent
- Full-time
- 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.
- 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.