VP, GCP Quality & Clinical Compliance — Hybrid

Kriya Therapeutics, Inc.; North Carolina; Híbrido; USD 230.000 - 320.000; Tempo integral

Benefícios oferecidos por esta vaga

Flexible Time Off

Company Holidays

Health Insurance

401(k) with Company Match

Resumo da vaga

Kriya Therapeutics, Inc. is seeking a Vice President of Clinical Quality Assurance to lead the GCP quality strategy across all clinical activities at our RTP, NC site and beyond. This senior leader will drive compliant, efficient processes to protect patient safety and data integrity while enabling speed.

The role requires extensive GCP QA experience, a strong regulatory knowledge base, and proven ability to scale a quality function in a growing company. Hybrid work and travel are expected.

Qualificações

• Degree in life sciences or health-related field; advanced degree preferred.
• 15+ years of relevant experience in biotech/pharma 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.

Responsabilidades

• 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 (e.g., quality issue management, CAPA, risk management, 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.

Conhecimentos

GCP QA leadership

Leadership

Vendor management

Audits (GCP, CROs, sites)

Regulatory knowledge (ICH E6 R3/E8 R1,

Formação

Advanced degree preferred (Masters/PhD/PharmD)

Bachelor's degree in life sciences or health-related field

Descrição da vaga

Kriya Therapeutics, Inc. is seeking a Vice President of Clinical Quality Assurance to lead the GCP quality strategy across all clinical activities at our RTP, NC site and beyond. This senior leader will drive compliant, efficient processes to protect patient safety and data integrity while enabling speed.

The role requires extensive GCP QA experience, a strong regulatory knowledge base, and proven ability to scale a quality function in a growing company. Hybrid work and travel are expected.