Director, Clinical Quality Assurance
The Director of Clinical Quality Assurance at Ray Therapeutics is responsible for leading the development, implementation, and maintenance of QA systems and quality oversight of Good Clinical Practices (GCP) operations. This role ensures clinical trials comply with guidelines and international regulations, such as ICH-GCP and ICH-PV, and applicable laws.
Essential Duties and Responsibilities
Ensure all clinical trial activities comply with guidelines and international regulations (e.g., ICH-GCP and ICH-PV), and applicable laws.
Create and implement clinical quality risk management strategies to identify, assess, and mitigate risks associated with clinical development and operations. This involves conducting risk assessments, developing risk mitigation plans, and overseeing their implementation.
Review and approve clinical trial protocols, informed consent forms (ICFs), clinical study reports (CSRs), risk management plans, and other GCP-critical documents to verify compliance with GCP requirements.
Review and negotiate Quality Agreements with CROs and external service providers.
Ensure trial master file (TMF) completeness and inspection-readiness.
Lead GCP audit program, including audit planning, execution, report writing, and escalation of critical findings.
Own clinical QA SOPs and associated documentation, ensuring alignment with GCP requirements, company QMS, and evolving industry best practices.
Oversee deviation and non-conformance management for clinical activities, driving thorough root cause investigations and robust CAPA plans.
Lead GCP training strategy and program for clinical staff, investigators, and site personnel.
Establish and report clinical quality metrics and key performance indicators (KPIs) to senior leadership and at management review.
Support preparation of risk-benefit communications and quality-related clinical narratives for agency interactions.
Champion a culture of quality and patient safety through cross-functional education, proactive risk identification, and constructive engagement with internal and external stakeholders.
Qualifications and Experience
Bachelor's degree(s) in Biological Sciences, Chemistry, or related Science discipline with at least 10 years of experience in clinical quality assurance (GCP, GLP and PV) in cell & gene therapy/biotechnology and/or pharmaceutical industry.
Deep expertise in GCP regulations and guidelines.
Certification in quality assurance (e.g., Certified Quality Auditor) and/or GCP (e.g., Certified Clinical Research Professional) is desirable.
Demonstrated experience conducting and managing clinical site audits, CRO audits, and internal GCP audits.
Strong written and verbal communication skills, including the ability to distill complex compliance topics for varied audiences.
Compensation Range and Benefits
The anticipated base salary range for this role is $195,000 to $215,000, based on the candidate's professional experience level. Ray Therapeutics also offers annual performance-based bonus, annual equity awards, and a comprehensive benefits package.