Director, Clinical Quality Assurance

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 Director of Clinical Quality Assurance is responsible for the development, implementation, and oversight of the clinical quality management system.  This role is responsible for ensuring GCP compliance across internal processes, clinical research organizations, and clinical suppliers.  The ideal candidate will have extensive GCP experience, a proactive approach to risk management, and experience in developing a quality system in a fast-paced, early-phase environment.  The ideal candidate can identify GCP gaps and effectively collaborate with Clinical Operations, Regulatory and other departments to ensure Kriya’s QMS aligns with GCP and Regulatory requirements.  

How You Contribute

• Quality Management Systems: Work with the Quality, Regulatory, and Clinical Operations teams to develop and implement the clinical quality assurance strategy aligned with company goals and regulatory expectations. Drive continuous improvement initiatives and CAPA management for clinical quality.
• GCP Compliance Oversight: Ensure Kriya’s compliance with ICH-GCP, FDA, EMA and other applicable regulations across all clinical programs.  Provide the quality oversight of CROs, and other clinical vendors supporting Kriya programs. Provide reviews and guidance on clinical trial documents and reports.
• Risk Management: Collaborate with cross-functional teams to identify and mitigate risks related to clinical trials from multiple perspectives.  These activities include but are not limited to clinical documents and protocols, CROs, laboratories, clinical sites, audit findings, deviations and CAPAs.  Use tools like risk matrices to evaluate the likelihood and impact of identified risks. Stay up to date on evolving GCP regulations and assess their impact on ongoing and planned studies.
• SOP Development: Establish and maintain GCP-related SOPs and quality systems to support clinical operations.  Ensure the Quality by Design approach and risk-based thinking is incorporated into clinical processes and procedures.  
• Audit Program Support: Provide Lead Auditor support and/or audit support, as needed for clinical vendors and CROs.  Prepare for and participate in regulatory inspections.
• Vendor Management: lead vendor qualifications and work closely with Contract Research Organizations (CROs) to maintain quality standards in outsourced activities. Assist in additional Quality Assurance clinical vendor initiatives as applicable.
• Biologics Expertise: Leverage your knowledge of biologics drug development to enhance quality processes specific to AAV based gene therapies.

What You Bring to the Team

Education & Experience

• Bachelor’s degree in Life Sciences or related field; advanced degree preferred.
• Minimum of 10 years of experience in clinical quality assurance within the pharmaceutical or biotechnology industry.
• Auditor training and certification preferred.

Competencies

• Mastery of ICH-GCP, FDA, EMA, and other global regulatory guidelines.
• Ability to interpret and apply evolving regulations to clinical programs. 
• Ability to develop and implement a risk-based quality strategy aligned with business goals.
• Forward-looking mindset to anticipate compliance challenges and industry trends.
• Understanding of clinical trial design, execution, and data flow.
• Familiarity with early-phase trial complexities, including first-in-human studies. 
• Proficient in identifying, assessing, mitigating, and monitoring clinical quality risks.
• Experience in implementing QbD and risk-based approach into the clinical quality processes.
• Strong written and verbal communication skills for interacting with internal teams, vendors, and regulators.
• Ability to translate complex