Head of Quality Assurance, Clinical Research

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

📋 Description

• Annually review, update, and manage the company's Standard Operating Procedures (SOPs), processes, and policies.

• Identify gaps in processes and implement necessary improvements.

• Coordinate with Corporate Operations regarding employee training needs and documentation.

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

• Lead and/or engage in critical projects that promote continuous quality enhancements.

• Oversee the scheduling, performance, reporting, and follow-up of internal Quality Assurance audits.

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

• Create and present regular Quality Assurance metrics reports to leadership.

• Evaluate Quality Assurance growth and development needs in alignment with company objectives.

• Provide guidance, interpretation, support, training, and input to development teams concerning regulations, guidelines, corporate standards, and policies.

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

• Supervise the Quality Assurance staff, including planning, assigning, and directing tasks, conducting evaluations, and facilitating professional growth.

• Stay updated on industry trends, standards, and policies, including FDA, Good Clinical Practice (GCP), and EU regulations.

• Carry out additional duties as assigned.

• Report directly to the Chief Operating Officer (COO).

⛳️ Requirements

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

• 5-7 years of experience in Quality Assurance within the pharmaceuticals, Contract Research Organizations (CRO), and/or site networks.

• 5-7 years of management experience.

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

• Leadership experience in Quality Assurance within highly regulated environments.

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

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

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

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

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

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

• Capable of lifting up to 15 pounds occasionally.

🏝️ Benefits

• Competitive salary package.

• Comprehensive benefits package.

• Opportunities for professional advancement.

• A supportive and dynamic research environment.