Senior Clinical QA Manager (Contract) - Remote/GCP

Kriya Therapeutics, Inc.; Morrisville (NC); Hybrid; USD 96,000 - 152,000; Part time

Job summary

Kriya Therapeutics, Inc. is seeking a Senior Manager, Clinical Quality Assurance (Contract) to apply GCP, ICH, and regulatory requirements across the QMS.

You will own standards, training, and oversight for clinical trial activities, SOPs, the eQMS Clinical module, and GCP training. Responsibilities include QA supervision of CROs, vendors, and trial sites, plus proactive guidance to study teams, risk identification, and CAPA development to ensure inspection readiness and continuous quality

Qualifications

• Bachelor’s degree in a scientific field; advanced degrees preferred.
• 7–10 years of clinical quality/operations experience in biotech/pharma/CRO.
• GCP/ICH/FDA knowledge with QMS/SOP experience; exposure to audits and CAPAs.

Responsibilities

• Review and oversee clinical QA documentation (SOPs, protocols, ICFs, reports).
• Ensure compliance with GCP, ICH, and internal procedures across trials.
• Lead audits of CROs, vendors, and sites; manage CAPAs and quality events.

Skills

GCP knowledge

ICH guidelines

FDA regulations

Regulatory requirements

QMS experience

SOP development

Audits and CAPAs

Independent work

Communication

Organization

Problem-solving

Collaboration

Ownership

Education

Bachelor’s degree in scientific field

Advanced degree preferred

Job description

Kriya Therapeutics, Inc. is seeking a Senior Manager, Clinical Quality Assurance (Contract) to apply GCP, ICH, and regulatory requirements across the QMS.

You will own standards, training, and oversight for clinical trial activities, SOPs, the eQMS Clinical module, and GCP training. Responsibilities include QA supervision of CROs, vendors, and trial sites, plus proactive guidance to study teams, risk identification, and CAPA development to ensure inspection readiness and continuous quality