VP, Clinical Quality & GCP Compliance

Kriya Therapeutics, Inc.; Morrisville (NC); Hybrid; USD 250,000 - 360,000; Full time

Benefits offered by this job

Flexible Time Off

Medical Insurance

401(k) with Company Match

Job summary

Kriya Therapeutics, Inc. seeks a Vice President of Clinical Quality Assurance to lead GCP quality strategy across all clinical activities and ensure compliance while enabling efficiency and patient safety.

The role partners with Clinical Development, Regulatory, and Operations to implement scalable quality systems and drive inspection readiness, CAPA execution, and risk-based oversight across vendors, sites, and trials.

Qualifications

• Degree in scientific or health-related discipline required; advanced degree preferred.
• 15+ years in biotech/pharma with GCP QA experience.
• Experience leading and developing people, including managers or senior ICs.
• Experience conducting/overseeing GCP audits (sites, CROs, vendors, TMF).
• Knowledge of ICH E6(R3) & E8(R1), FDA/EMA regulations, risk-based quality management.

Responsibilities

• Own GCP compliance across all clinical activities, including CROs, vendors, and sites.
• Provide proactive, risk-based GCP input to Clinical Study Teams.
• Develop and execute clinical site audit strategy and risk-based prioritization.
• Lead Clinical Quality Council to review trends, CAPAs, and cross-functional decisions.
• Design and implement quality systems (CAPA, risk management, quality metrics) scalable to study/program risk.
• Partner with Clinical Development, Clinical Operations, Regulatory to build a culture of quality.
• Lead inspection readiness and support regulatory inspections.
• Report quality performance and risks to senior leadership.
• Coach and develop the clinical quality team.

Skills

GCP quality

Leadership

Regulatory knowledge

Audits

Cross-functional collaboration

Stakeholder management

Quality strategy

Education

Bachelor’s degree in science/health

Advanced degree preferred (Master/PhD/PharmD)

Job description

Kriya Therapeutics, Inc. seeks a Vice President of Clinical Quality Assurance to lead GCP quality strategy across all clinical activities and ensure compliance while enabling efficiency and patient safety.

The role partners with Clinical Development, Regulatory, and Operations to implement scalable quality systems and drive inspection readiness, CAPA execution, and risk-based oversight across vendors, sites, and trials.