Head of Quality Assurance – Clinical Research

This is a fully remote position, open to applicants in Texas.

📋 Description

• Annually review, revise, and oversee the company's SOPs, processes, and policies.

• Identify inefficiencies in processes and implement enhancements.

• Collaborate with Corporate Operations regarding employee training needs and related documentation.

• Develop, maintain, and enforce Quality Assurance Plans across all departments.

• Lead or participate in key projects that promote continuous quality enhancements.

• Oversee the scheduling, performance, reporting, and follow-up of Internal QA Audits.

• Guide and assist sites during inspections and inquiries from regulatory agencies.

• Create and deliver regular QA metrics reports to leadership.

• Evaluate QA growth and development requirements aligned with company objectives.

• Offer guidance, interpretation, support, training, and insights on regulations, guidelines, corporate standards, and policies.

• Manage the documentation, reporting, and resolution of significant compliance issues.

• Supervise QA personnel, including planning, assigning, directing work, conducting evaluations, and fostering professional development.

• Stay updated on industry trends, standards, and policies, including FDA, GCP, and EU requirements.

• Undertake additional duties as assigned.

• Reports directly to the COO.

⛳️ Requirements

• Proven experience in scheduling, planning, and conducting regulatory inspections as well as internal and external audits.

• Leadership experience in Quality Assurance within highly regulated settings.

• Experience in developing teams and departments in medium to large organizations.

• In-depth, up-to-date knowledge of clinical research requirements, processes, and best practices.

• Bachelor’s and/or Master’s degree in a scientific or healthcare-related discipline.

• 5-7 years of Quality Assurance experience in pharmaceuticals, CRO, and/or site networks.

• 5-7 years of management experience.

• Good Clinical Practice (GCP) certification/training every three years.

• Maintain relevant medical licenses, certifications, etc., as applicable.

• Ability to sit for extended periods at a desk and work on a computer.

• Must be capable of lifting up to 15 pounds occasionally.

• Willingness to travel up to 25% of the time.

🏝️ Benefits

• Competitive salary.

• Comprehensive benefits package.

• Opportunities for professional development.

• Supportive and dynamic research environment.