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.”

Responsibilities

The Sr. Manager, Clinical Quality Assurance (contract) is an internal expert on how GCP, ICH, and global regulatory requirements are applied across Kriya's QMS, owning the standards, training, and oversight that keep clinical trial activities audit-ready. This role sets the approach on Clinical SOPs, the DOT eQMS Clinical module, and GCP training, and provides QA oversight of CROs, vendors, and quality events throughout trial conduct.

Key Responsibilities

Review and provide oversight of clinical QA documentation including SOPs, protocols, ICFs, reports, and study-level documents
Collaborate with Clinical Operations teams in maintaining compliance with GCP, ICH, and internal procedures
Perform quality assessments on clinical processes, documentation, and outputs
Maintain accurate documentation of quality activities, including deviations, CAPAs, and quality events
Apply expertise to define standards for SOP development, revision, and implementation
Serve as a QA subject matter expert for assigned clinical studies or programs
Provide proactive quality guidance to study teams, identifying risks and leading mitigation strategies
Lead audits of CROs, vendors, and investigator sites
Oversee vendor qualification and oversight activities
Ensure audit findings are tracked and addressed appropriately
Own investigation of quality events and deviations
Drive root cause analysis and CAPA development
Track CAPAs and coordinate timely closure
Provide expertise for inspection readiness activities (e.g., document review, gap assessments, back-room support)
Partner with Clinical Operations and other functions to support quality across clinical programs
Spearhead development of tools, templates, and quality metrics
Contribute to continuous improvement initiatives within the QMS

Skills

Experience & Skills

Bachelor’s degree in a scientific or related discipline (advanced degree preferred)
7–10 years of experience in clinical quality and/or clinical operations in a biotech, pharmaceutical, or CRO environment
Experience in gene therapy, biologics, or advanced therapeutics strongly preferred
Strong knowledge of GCP, ICH guidelines, FDA regulations, and global regulatory requirements
Experience with Quality Management Systems (QMS) and SOP development
Exposure to audits, CAPAs, and inspection readiness activities
Ability to work independently while operating effectively in a collaborative environment
Strong problem-solving and critical thinking skills
Excellent communication and interpersonal skills
High level of organization and ability to manage multiple priorities
Willingness to take on increasing responsibility and ownership

Work Environment

Remote or hybrid (as applicable)
Work is normally performed: at a desk
Lifting requirements: Under 20 lbs
Travel requirements: Occasional
Must be willing to work outside of normal business hours, as necessary, to support the clinical project team members on different time zones.

Benefits

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.