Quality Assurance Lead

DM Clinical Research; Houston (TX); On-site; USD 70,000 - 90,000; Full time

Job summary

A clinical research organization in Houston seeks a Quality Assurance Lead to oversee QA functions, manage quality assurance programs, and ensure compliance with FDA regulations. The ideal candidate will have 3 years of clinical research experience and leadership skills. Responsibilities include overseeing audits, mentoring teams, and reporting trends to management. Certification in QA is preferred. This role is vital for enhancing quality in clinical research and ensuring successful trial processes.

Qualifications

• 3 years of clinical research experience.
• 1-2 years experience as QA Associate.
• Related certifications (CCRP, CCRA, CCRC, or similar) preferred.

Responsibilities

• Oversee quality assurance functions including audits and inspections.
• Develop and maintain quality assurance programs and policies.
• Educate and mentor the research team on regulatory requirements.

Skills

Effective organization

Communication skills

Leadership skills

Ability to lead and manage multiple responsibilities

Job description

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

• 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

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