Manager, Quality Assurance Audits and Supplier Qualifications

About Kriya 

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.”

Who You Are

The Manager of Quality Assurance Audits and Supplier Qualifications is responsible for supporting the day-to-day execution of the supplier quality qualification program. This role requires strong attention to detail, effective communication skills, and adaptability to changing business needs. The primary focus of this position is to support the advancement of Kriya’s Clinical programs by providing quality assurance support. The GxP Auditor plays a crucial role in Kriya’s programs by performing external risk-based audits of contract manufacturing organizations (CMOs), contract research organizations (CROs), contract testing organizations (CTOs), vendors, clinical sites, and suppliers. They are responsible for vendor oversight and ensuring day-to-day compliance, including quality event management, escalation, and change management. 

How You Contribute

• Support the planning and maintenance of the annual audit program schedule, including coordinating audits as assigned.
• Lead, perform, and report on audits addressing qualification, routine, or critical issues at CMOs, CROs, CTOs, vendors, suppliers, and clinical sites. Ensure their quality and production systems comply with regulatory, GxP, and Company SOPs.
• Write and issue audit reports in accordance with Kriya SOPs, templates, and timelines, ensuring clear communication of audit findings to the project team.
• Evaluate responses to audit findings, track deliverables, and follow up on actions to closure (e.g., CAPAs, ECs) to ensure timely completion, effectiveness, and quality.
• Assess, prepare, and process change controls for changes submitted by supplier sites for material and supplier-related changes.
• Manage the review, negotiation, and signature gathering of Quality Agreements to ensure all parties are aligned and compliant.
• Evaluate the impact of changes on systems, documentation, and product quality. Monitor the completion of change control action items and track changes to closure.
• Author, review, and revise site SOPs to ensure compliance with GMPs, regulatory requirements, and corporate standards.
• Assist in managing and maintaining Quality Assurance documentation.
• Participate in quality system improvements to enhance overall efficiency and compliance.
• Perform other duties as assigned by Quality Assurance Management, contributing to the overall success of the team.

What You Bring to the Team

Education & Experience

• Bachelor’s degree in science/technical field (e.g., biochemistry, bioengineering, clinical research, etc.), or equivalent combined education and experience; Master’s degree a plus
• Minimum of 5 years of experience in Quality Assurance within the pharmaceutical, biotechnology, or related industry.
• Proven experience in conducting GxP audits, including CMOs, CROs, CTOs, vendors, and suppliers.
• Demonstrated ability to manage supplier qualification activities and change controls.
• Experience working in small to mid-size pre-IND to commercial organization a plus
• Extensive experience in GxP auditing covering GMP, GVP, and GLP functions; GCP experience a plus
• Auditor experience required, certifications a plus
• Strong computer skills (preferably MS Office, Adobe Acrobat Pro, DocuSign and Dot Compliance)

Competencies

• Commitment to maintaining high standards of quality and ensuring compliance with regulatory requirements and company SOPs.
• Current and strong working knowledge, interpretation, and implementation of United States FDA Regulations, ICH Guidelines, and other local government regulatory requirements governing biopharmaceutical research
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