Relevant degree in a scientific or health-related discipline; advanced degree preferred.
15+ years of experience in biotechnology or pharmaceuticals, or 10+ years with an advanced degree, focusing on GCP Quality Assurance.
Proven leadership experience in developing teams and managing senior contributors.
Expertise in conducting GCP audits and supporting health authority inspections.
In-depth knowledge of ICH E6 (R3), E8(R1), FDA, EMA regulations, and risk-based quality management principles.
Ability to balance compliance with efficiency and patient safety.
Experience in scaling clinical quality functions in small to mid-sized companies.
Responsibilities
Own GCP compliance across all clinical activities, overseeing CROs, vendors, and sites.
Provide proactive, risk-based GCP guidance in Program and Clinical Study Team meetings.
Develop and execute a risk-based clinical site audit strategy.
Lead the Clinical Quality Council to review quality trends and drive accountability.
Design and implement effective clinical quality systems and processes.
Foster a culture of quality and compliance across clinical functions.
Lead inspection readiness and support regulatory inspections.
Benefits
Flexible Time Off
Paid Parental & Medical Leave
Paid Company Holidays
Fertility & Family Building Benefits
Medical, Dental, and Vision Insurance
Employee Assistance Program (EAP)
Life Insurance
Short- and Long-Term Disability Coverage
Equity
401(k) with Company Match
Identity Theft Protection
Full Job Description
Vice President, Clinical Quality Assurance
Department: Clinical
Employment Type: Full Time
Location: Research Triangle Park, NC
Role Overview
The Vice President, Clinical Quality Assurance leads Kriya's GCP quality strategy and is accountable for GCP compliance across all Kriya clinical activities. This role implements and leads the systems and processes that drive quality effectiveness and compliance, and partners with clinical team to provide GCP guidance. The VP ensures quality oversight activities enable efficiency and speed while protecting patient safety, data integrity, and trial integrity.
Key Responsibilities
Own GCP compliance across all Kriya clinical activities, including oversight of CROs, vendors, and clinical sites.
Participate in Program Team and Clinical Study Team meetings, providing proactive, risk-based GCP input and guidance to the clinical organization.
Develop and ensure execution of the clinical site audit strategy, including risk-based selection and prioritization of sites, vendors, and systems.
Establish and lead the Clinical Quality Council to review quality trends, risks, deviations, and CAPAs, and to drive cross-functional decisions and accountability.
Designs, implements and lead clinical quality systems and processes (for example, quality issue management and escalation, CAPA, risk management, and quality metrics) that are effective, scalable, and right-sized to study and program risk.
Partner with leaders in Clinical Development, Clinical Operations, Regulatory, and other functions to build a culture of quality and shared ownership of compliance.
Lead inspection readiness and support regulatory authority inspections of clinical activities.
Report clinical quality performance and emerging risks to senior leadership.
Coach and develop direct reports; build and lead a high-performing clinical quality team.
15+ years of relevant experience in the biotechnology or pharmaceutical industry with a bachelor's degree, or 10+ years with an advanced degree, including substantial experience in a GCP Quality Assurance role.
Demonstrated experience leading and developing people, including managers or senior individual contributors.
Experience conducting or overseeing GCP audits (sites, CROs, vendors, TMF) and supporting health authority inspections.
In-depth knowledge of ICH E6 ( R3) & E8(R1), FDA, EMA and global clinical regulations, and risk-based quality management principles.
Proven ability to right-size quality oversight, balancing compliance and patient safety with speed and efficiency.
Experience building or scaling a clinical quality function in a small or mid-sized company, with willingness to be hands-on.
Strong influencing, communication, and partnership skills; sound judgment and ability to act as a trusted advisor to clinical leaders.
Experience in gene therapy or other complex-modality clinical development preferred.
Work Environment
Hybrid work arrangement (flexibility may be considered for the right candidate).
Primarily desk-based, generally in an office or home office setting; may involve extended periods of sitting and computer use.
Some travel required (for example, site audits, sponsor and vendor meetings, and inspections). Estimated travel: 30%.
Rewards & Benefits
Time Off & Work-Life Balance: Flexible Time Off • Paid Parental & Medical Leave • Paid Company Holidays
Health & Wellness: Fertility & Family Building Benefits • Medical, Dental, and Vision Insurance • Employee Assistance Program (EAP) • Life Insurance • Short- and Long-Term Disability Coverage
Financial Security:Equity • 401(k) with Company Match • Identity Theft Protection
And More!
About Kriya Therapeutics
Kriya Therapeutics is a clinical-stage biotechnology company developing transformative gene therapies for the treatment of highly prevalent serious diseases. The company's mission is to develop best-in-class gene therapies that restore normal gene function, thereby transforming the lives of patients with serious diseases. Kriya's pipeline includes multiple programs across various therapeutic areas, including ophthalmology, oncology, and rare genetic diseases. The company is headquartered in South San Francisco, California.
