Kriya Therapeutics, Inc. · 10 hours ago
Manager, Quality Assurance Validation (Contractor)
Morrisville, NC
Contract
Hybrid
Senior Level
5+ years expKriya Therapeutics, Inc. is a biopharmaceutical company focused on developing life-changing gene therapies. The Manager, Quality Assurance Validation Contractor is responsible for ensuring the integrity and compliance of equipment and processes within the GMP environment, providing quality assurance guidance throughout the validation program.
BiotechnologyHealth CareLife ScienceNeuroscience
Responsibilities
Collaborate with cross-functional teams to develop and execute a robust validation strategy for equipment, utilities, and computer software assurance (CSA), that align with regulatory requirements
Work with various departments to define the validation scope, deliverables, and timelines
Review and approve validation documents including SOPs, protocols, specifications, test scripts, acceptance criteria, and reports
Ensure implementation, operation, and validation of GXP computerized systems follow GAMP 5 guidelines
Participate in risk assessments related to GXP equipment, utilities, and computerized systems
Identify and address potential risks to data integrity, security, and safety
Provide quality support for change control processes and activities that occur for any modifications to existing or new systems, equipment, instruments, or utilities to ensure validation requirements are assessed and fulfilled
Review/approve validation exception records and investigations
Opportunity to participate in CSV vendor audits
Support biennial reviews of validated systems as required
Provide various quality support in other areas of Quality that include batch record review, data review, material release, vendor and regulatory audits, SOP review, and other document reviews, as needed
Qualification
Required
5+ years of industry experience
Minimum – Bachelor's or Masters's degree preferably in an Engineering, Science, Technical, or related fields
Minimum of three (3) years of experience in Quality Assurance and Validation within the biotechnology workforce
Thorough knowledge of applicable regulations and standards related to validation activities
Experience working in a cGMP environment
Detailed knowledge of GAMP 5 applications and CSA approach
Proficiency in Microsoft Suite
Ability to manage daily work activities of this role with minimal supervision
Strong orientation for quality and cGMPs
Strong collaborative skills
Highly self-motivated and detail oriented
Demonstrated level of respect for individuals
High level of integrity and personal responsibility
Preferred
Relevant certifications such as CQA are preferred
Company
Kriya Therapeutics, Inc.
Our mission is to revolutionize medicine, with the ultimate goal of eliminating human suffering and enabling people to live without the burden of disease.
51-200 employees
H1B Sponsorship
Kriya Therapeutics, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (1)
2022 (3)
Funding
Current Stage
Late StageTotal Funding
$921.32MKey Investors
Patient Square CapitalQVT FinancialTranshuman Capital
2025-08-15Series D· $320.82M
2023-07-26Series C· $150M
2022-05-16Series C· $270M
Leadership Team
Shankar Ramaswamy
Co-Founder and Chief Executive Officer
Sachiyo Minegishi
Chief Financial Officer
Recent News
2026-01-05
Kriya Therapeutics, Inc.
2025-12-01
Company data provided by crunchbase