Manager, Quality Assurance Systems
Kriya Therapeutics
Research Triangle Park, NC
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JOB DETAILS
LOCATION
Research Triangle Park, NC
POSTED
14 days ago
Description
Kriya is a biopharmaceutical company whose mission is to develop life-changing gene therapies for diseases affecting millions of patients around the world.
We leverage our proprietary computational engine, in-house manufacturing infrastructure, and integrated design platform to engineer technologies and therapeutics with the potential to transform the treatment of a broad universe of diseases of high unmet need, with a focus on metabolic disorders, neurology, and ophthalmology.
We are proud to have been named Triangle Business Journal’s Life Sciences 2024 “Best Private Company to Work For,” recognized by Forbes as one of “America’s Best Startup Employers of 2024,” and honored as one of BioSpace’s “2025 Best Places to Work.”
We leverage our proprietary computational engine, in-house manufacturing infrastructure, and integrated design platform to engineer technologies and therapeutics with the potential to transform the treatment of a broad universe of diseases of high unmet need, with a focus on metabolic disorders, neurology, and ophthalmology.
We are proud to have been named Triangle Business Journal’s Life Sciences 2024 “Best Private Company to Work For,” recognized by Forbes as one of “America’s Best Startup Employers of 2024,” and honored as one of BioSpace’s “2025 Best Places to Work.”
Role Overview
We are seeking an experienced Quality Systems professional to serve as Business Owner for our Dot Compliance electronic Quality Management System (eQMS). This role is critical to maintaining and optimizing our quality management infrastructure, ensuring regulatory compliance, and driving continuous improvement initiatives. The successful candidate will act as the primary liaison between our organization and Dot Compliance, serving as the Subject Matter Expert for all eQMS workflows and system administration activities. Beyond eQMS administration, this role will also serve as the Quality System SME for select quality systems, with responsibility for monitoring system performance, ensuring governing SOPs remain compliant with applicable regulations, and leading continuous improvement efforts. This position requires a detail-oriented professional who can balance technical system administration with strategic quality management oversight in a GMP-regulated environment.
Key Responsibilities
Key Responsibilities
- Act as Business Owner for the Dot Compliance eQMS platform, including all system upgrades, implementations, and ongoing optimization.
- Review and approve Computer System Validation (CSV) documentation and partner with the CSV team to develop and execute a comprehensive QMS roadmap.
- Serve as primary point of contact with Dot Compliance for system issues, enhancement requests, customizations, upgrades, and contract management.
- Manage user access requests, permissions, role assignments, and maintain system administration procedures and SOPs.
- Act as Subject Matter Expert (SME) for Dot Compliance system workflows, developing training materials and delivering training programs to end users.
- Serve as a system expert for designated QMS modules (e.g., deviations, change control, CAPA), providing technical guidance, troubleshooting support, and subject matter expertise to ensure optimal system performance and compliance.
- Monitor and report on the health of assigned quality systems, driving continuous improvement and user capability.
- Ensure adherence to GMP, FDA regulations, 21 CFR Part 11, and applicable quality standards while maintaining audit readiness.
- Monitor system performance, identify issues, implement corrective actions, and drive continuous improvement initiatives.
- Maintain system lifecycle documentation including URS, risk assessments, and validation protocols.
- Support the documentation lifecycle by managing archival processes, ensuring proper retention, retrieval, and disposal of electronic records in compliance with regulatory requirements for document control.
- Support regulatory audits and inspections related to the eQMS and ensure system security and data integrity compliance.
- Performs other duties as assigned.
Experience & Skills and Work Environment
Experience & Skills
- Bachelor's degree in Life Sciences, Engineering, Computer Science, or related discipline (or equivalent experience).
- Minimum 8 years of experience in a GMP-regulated pharmaceutical or life sciences environment.
- Demonstrated experience with eQMS platform administration (Dot Compliance, or similar systems).
- Proven experience with Computer System Validation (CSV) activities and documentation.
- Strong understanding of Quality Management System processes including Change Control, CAPA, Deviations, and Document Control.
- Working knowledge of CSV principles and GAMP 5 guidelines with experience reviewing validation documentation (IQ/OQ/PQ protocols).
- Familiarity with GMP, FDA regulations, and 21 CFR Part 11 requirements.
- Excellent communication skills with ability to translate technical concepts for diverse audiences.
- Strong project management capabilities with proven ability to work independently and manage multiple priorities.
- Highly organized with strong attention to detail and analytical thinking skills.
- Experience influencing and driving system adoption across cross-functional teams.
Work Environment
- Primarily desk-based, generally in an office or home office setting.
- May involve extended periods of sitting and computer use.
Life at Kriya
Discover True Collaborative Teamwork
We have an ambitious set of goals, but our confidence – and our inspiration – stems from our people. From California to North Carolina, our teammates bring a spirit of Collaboration, Leadership, and Innovation to their work every day.
We’re always looking for teammates with the drive and energy to help us grow. If you want to be a part of a company with an entrepreneurial culture, a bold vision, and a meaningful purpose, join us.
Rewards & Benefits
We have an ambitious set of goals, but our confidence – and our inspiration – stems from our people. From California to North Carolina, our teammates bring a spirit of Collaboration, Leadership, and Innovation to their work every day.
We’re always looking for teammates with the drive and energy to help us grow. If you want to be a part of a company with an entrepreneurial culture, a bold vision, and a meaningful purpose, join us.
Rewards & Benefits
- Time Off & Work-Life Balance: Flexible Time Off Paid Parental & Medical Leave Paid Company Holidays
- Health & Wellness: Fertility & Family Building Benefits Medical, Dental, and Vision Insurance Employee Assistance Program (EAP) Life Insurance Short- and Long-Term Disability Coverage
- Financial Security:Equity 401(k) with Company Match Identity Theft Protection
- And More!
About the Company
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