Vice President, Clinical Quality Assurance

Kriya Therapeutics•Durham, NC

3d•Hybrid

About The Position

Kriya is a biopharmaceutical company developing gene therapies for diseases with high unmet need, with a focus on metabolic disorders, neurology, and ophthalmology. The Vice President, Clinical Quality Assurance leads Kriya’s GCP quality strategy and is accountable for GCP compliance across all clinical activities. The role implements and leads systems and processes that promote quality effectiveness and compliance, while partnering with the clinical team to provide GCP guidance and protect patient safety, data integrity, and trial integrity. This leader oversees GCP compliance across clinical activities, including CROs, vendors, and clinical sites; provides proactive, risk-based guidance to clinical teams; develops clinical site audit strategy; and establishes a Clinical Quality Council. The role builds scalable clinical quality systems and processes, partners across functions to foster shared ownership of compliance, leads inspection readiness, reports quality performance and emerging risks to senior leadership, and develops a high-performing clinical quality team. The position is based in a hybrid work arrangement, with flexibility potentially considered for the right candidate. Work is primarily desk-based in an office or home office, with extended sitting and computer use. Some travel is required, estimated at 30%, for activities such as site audits, sponsor and vendor meetings, and inspections.

Requirements

Relevant degree in a scientific or health-related discipline.
15+ years of relevant biotechnology or pharmaceutical industry experience 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 of sites, CROs, vendors, and TMF, and supporting health authority inspections.
In-depth knowledge of ICH E6 (R3), ICH E8(R1), FDA, EMA, and global clinical regulations, and risk-based quality management principles.
Ability to right-size quality oversight while 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.

Nice To Haves

Advanced degree, such as a Master’s, PharmD, or Ph.D.
Experience in gene therapy or other complex-modality clinical development.

Responsibilities

Own GCP compliance across Kriya clinical activities, including oversight of CROs, vendors, and clinical sites.
Participate in Program Team and Clinical Study Team meetings and provide proactive, risk-based GCP input and guidance.
Develop and execute 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 drive cross-functional decisions and accountability.
Design and lead effective, scalable, risk-appropriate clinical quality systems and processes, including quality issue management and escalation, CAPA, risk management, and quality metrics.
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 and build and lead a high-performing clinical quality team.