Kriya Therapeutics

Develops gene therapies; licenses collaborations

Manager – Computer Software Assurance & Validation

Regulatory & Quality (Life Sciences)Updated on Nov 14

Full-timeResearch Triangle Park, Durham, NC, USANo salary listed

About the Job

Requirements

A bachelor's degree in engineering or a life-science-related field is required.
At least seven years of Computer System Validation (CSV) experience in cGMP pharmaceutical or biopharmaceutical environments is required.
Deep knowledge of FDA regulations, including 21 CFR Part 11 and 21 CFR Part 820, GAMP 5, and risk-based computer software assurance is required.
Experience validating domain- and process-controlled systems, building monitoring and alarm systems, historians, and test automation tools or frameworks is required.
Experience with laboratory analytical instrument qualification and cloud-based validation is required.
Strong knowledge of data integrity practices, including MHRA and PIC/S guidance, is required.
Working knowledge of FDA, EU, and ICH regulations, as well as experience supporting regulatory inspections, is required.
Excellent communication, technical writing, and time management skills are required.
Strong interpersonal and organizational skills, attention to detail, proactive problem-solving, and effective collaboration across all levels of the organization are required.
The ability to independently lead multiple CSV projects for complex systems and digital initiatives, manage testing efforts, and ensure compliance is required.

Responsibilities

Lead Kriya's Computer System Validation (CSV) program and manage continuous improvement efforts for the program.
Implement risk-based computer system validation approaches and methodologies based on GAMP 5, including critical thinking and the computer software assurance (CSA) approach.
Provide oversight for the CSV program and contribute to the creation, support, and maintenance of standard operating procedures, work instructions, and forms, including authoring and revising them.
Represent CSV on projects and initiatives, and contribute to planning, development, and implementation of computer system validation documentation.
Oversee development of validation documentation, including System Impact Assessments, User Requirements Specifications, Validation Plans, Risk Assessments, Test Protocols, and other deliverables, in accordance with CSV procedures and the CSA approach to testing.
Review and audit computer system validation deliverables for compliance with 21 CFR Part 11, Annex 11, and other regulatory requirements.
Ensure data integrity assessments are executed and gaps identified through validation testing or procedural controls are resolved or mitigated.
Partner with Business Owners and Quality to ensure data integrity controls are effective and compliant.
Review and approve change control activities for computerized systems.
Own and maintain the computerized system inventory.
Provide CSV oversight for manufacturing-related systems, including domain- and process-controlled systems, building monitoring and alarm systems, and process historians.
Partner with Automation, Manufacturing, and Facilities to validate computerized systems supporting GMP production, utilities, and building management.
Ensure manufacturing systems maintain a validated state through implementation, change control, periodic review, and retirement.
Review and approve periodic review activities for computerized systems.
Provide leadership and guidance to cross-functional teams to achieve company objectives and team goals, supporting on-time completion of system go-lives and enhancements.
Oversee creation and authoring of standard operating procedures, policies, and the validation master plan as needed for the CSV program.
Oversee contract validation support.

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.”

The Manager, Computer Software Assurance & Validation, leads Kriya's CSV program. This role sets validation strategy, drives continuous improvement, and enforces data integrity controls across computerized systems. The Manager engages at every stage of software implementation, from planning through retirement, and ensures compliance with applicable regulatory requirements.

Key Responsibilities

Lead the Computer System Validation (CSV) program, including lead and manage continuous improvement efforts for the CSV program.
Implement risk-based computer system validation approach/methodologies based on GAMP 5, including critical thinking and computer software assurance (CSA) approach.
Provide oversight for the CSV program; provide input to, author, revise in creation, support and maintenance of SOPs, work instructions or forms.
Represent CSV on projects/initiatives, and provide input into the planning, development, and implementation of computer systems validation documentation.
Oversee the development of validation documentation (e.g., System Impact Assessment, User Requirements Specification, Validation Plan, Risk Assessment, Test Protocols, and other deliverables) according to CSV procedures and following the CSA approach regarding testing.
Review and audit of computer system validation deliverables according to 21 CFR Part 11, Annex 11 and other regulatory requirements.
Ensure the execution of data integrity assessments, including resolution/mitigation of gaps identified through validation testing or procedural controls.
Partner with Business Owners and Quality to ensure data integrity controls are effective and compliant.
Review and approve change control activities for computerized systems.
Own and maintain the computerized system inventory.
Provide CSV oversight for manufacturing-related systems, including domain and process-controlled systems, building monitoring and alarm systems, and process historians.
Partner with Automation, Manufacturing, and Facilities to validate computerized systems supporting GMP production, utilities, and building management.
Ensure manufacturing systems maintain a validated state across implementation, change control, periodic review, and retirement.
Review and approve periodic review activities for computerized systems.
Provide leadership and guidance to and collaborative with cross-functional teams to accomplish company objectives and team goals to support on-time completion of system go-lives and enhancements.
Oversee creation/authoring of standard operating procedures, policies, and validation master plan on an as-needed basis as it relates to the CSV program.
Oversee contract validation support.

Experience & Skills

Minimum bachelor’s degree in engineering or life science related field.
Minimum seven (7) years of CSV experience in cGMP pharmaceutical or biopharmaceutical environments.
Deep knowledge of FDA regulations (21 CFR Part 11, 21 CFR Part 820), GAMP 5, and risk-based computer software assurance.
Experience validating domain- and process-controlled systems, building monitoring/alarm systems, historians, and test automation tools/frameworks.
Experience with laboratory analytical instrument qualification and cloud-based validation.
Strong knowledge of data integrity practices, including MHRA and PIC/S guidance.
Working knowledge of FDA, EU, and ICH regulations, with experience supporting regulatory inspections.
Excellent communication, technical writing, and time management skills.
Strong interpersonal and organizational skills, with attention to detail, proactive problem-solving, and effective collaboration across all levels of the organization.
Proven ability to independently lead multiple CSV projects for complex systems and digital initiatives, managing testing efforts and ensuring compliance.

Work Environment

Primarily desk-based, generally in an office or home office setting.
May involve extended periods of sitting and computer use.
This is an onsite role at our Research Triangle Park site.

About the Company

Kriya Therapeutics

Develops gene therapies; licenses collaborations

Kriya Therapeutics develops gene therapies for widespread diseases and monetizes these programs through licensing and collaboration agreements. Its gene therapies target genetic or biological drivers of conditions such as Geographic Atrophy, Diabetic Retinopathy, and NASH, with a focus on ophthalmology. The company advances programs by partnering with biotech and pharma companies to secure upfront payments, milestones, and potential royalties. Its goal is to become a leading gene therapy biopharmaceutical company by delivering safe, effective treatments and generating revenue through collaborations and eventual product sales.

Company size: 201-500
Company stage: Series D
Total funding: $920.5M
Headquarters: Morrisville, NC
Founded: 2019

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