Vice President, Clinical Quality Assurance Greater Durham, NC Area

Vice President, Clinical Quality Assurance

Department: Clinical

Employment Type: Full Time

Location: Research Triangle Park, NC

Description

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.”

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.

Experience & Skills and Work Environment

Experience & Skills

Relevant degree required (scientific or health-related discipline); advanced degree (e.g., Master's, PharmD, Ph.D.) preferred.

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%.

Life at Kriya

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.

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!