Quality Assurance Lead
Posted
Summary
Oversees quality assurance for a clinical research organization in Houston, TX: builds internal audit programs, maintains SOPs and quality documents, drives CAPA/root-cause investigations, and mentors teams on FDA regulations and GCP/ICH compliance. Requires 3 years of clinical research experience plus 1-2 years as a QA Associate.
Quality Assurance Lead
The Quality Assurance Lead oversees quality assurance functions for the organization including, but not limited to development and maintenance of quality assurance programs and policies, oversight of inspections and audits, and management of Quality Documents. Ensure productivity per the company's goals.
DUTIES & RESPONSIBILITIES
DUTIES & RESPONSIBILITIES
- Maintaining a working knowledge of current FDA regulations, GCP/ICH guidelines, organizational SOPs, guidance documents, and study protocols.
- Developing, implementing, and maintaining an internal audit monitoring system and schedule.
- Leading the ongoing development, management, and implementation of written processes for effectively managing clinical trials.
- Leading the reporting of trends and metrics from all clinical activities to aid in effective process improvement and risk control.
- Maintaining Standard Operating Procedures (SOPs) including periodic review and coordination of the initiation/revision of procedures and policies to ensure compliance with new/revised regulations and guidelines
- Ensuring quality incidents are investigated, root cause analysis is performed, and CAPA has been implemented and monitored for effectiveness.
- Performing Quality Documents review and approval (e.g. SOPs, guidance documents)
- Partnering with study teams to identify potential changes and opportunities for process improvement
- Educating and mentoring the research team with the interpretation of regulatory requirements (e.g., GCPs), SOP requirements, and other guidance documents, as applicable.
- Evaluating responses to monitoring and audit reports with the research team; follow-up with applicable stakeholders to ensure resolution.
- Functions within study teams to conduct feasibility assessments, and ongoing quality assurance reviews of clinical research studies, with the goal of assessing site readiness and developing site-specific education and processes as needed.
- Report quality assurance trends/metrics to Sr. Management.
- Any other matters as assigned by management.
KNOWLEDGE & EXPERIENCE
Education:
- Bachelor’s degree preferred
Experience:
- 3 years of clinical research experience
- 1-2 years experience as QA Associate
Credentials:
- Related certifications (CCRP, CCRA, CCRC, or similar) preferred
Knowledge and Skills:
- Effective organization, communication, and leadership skills
- Effective working relationships with coworkers, managers, and external clients
- Strong ability to lead and manage multiple responsibilities
- Ability to articulate and define departmental needs and processes