Quality Assurance Manager
FEFA LLC, United States
Job Description
FEFA LLC is seeking a Quality Assurance Manager who will play a vital role in ensuring industry-standard operations and quality management of clinical trials for deafness and other communication disorders. This role involves conducting various activities to effectively assess, advise, and assist research teams in implementing quality management procedures and protocols. The Quality Assurance Manager will also provide evaluation, advice, and technical expertise on quality control, quality assurance, and quality improvement for clinical trial implementation. Some travel to clinical sites will be required.
Key Responsibilities:
Quality Management Oversight:
- Review and modify the Pre-Implementation checklist in collaboration with the research team, ensuring compliance with industry standards and regulatory requirements.
- Evaluate clinical trial operations at research coordinating and performance sites, providing guidance on quality control, assurance, and improvement procedures.
- Assist in the development and incorporation of quality management procedures into clinical trial operations, including the creation of tools such as templates, outlines, and guidance documents.
- Review and provide feedback on quality management SOPs submitted by research teams, ensuring adherence to protocol, GCP, and regulatory requirements.
- Verify that pre-implementation/implementation study team documents and SOPs address NIH and regulatory requirements, providing recommendations for improvement as necessary.
Site Initiation Visits and Training:
- Develop a comprehensive plan and user-friendly tools for conducting site initiation visits.
- Conduct evaluations of coordinating and performance sites' infrastructure, organizational structure, communication procedures, and staff quality and training for clinical trials.
- Verify site readiness to initiate clinical trials, providing recommendations for activation and evaluating key aspects such as staff training, infrastructure, and recruitment plans.
- Provide verbal debriefings and written reports on major deficiencies observed during site visits, advising on corrective actions and SOP revisions as needed.
- Train study coordinators and delegated study team staff to conduct effective subsite initiation visits and interim visits to monitor trial implementation and data integrity independently.
Reporting and Evaluation:
- Provide study research teams with evaluation reports identifying issues and recommending solutions to address them.
- Collaborate with research teams and coordinating centers to ensure timely resolution of issues and implementation of corrective actions.
Requirements
Qualifications and Skills:
- Bachelor's degree in a relevant field (e.g., life sciences, healthcare management).
- Minimum of 5 plus years experience as quality assurance auditor/technician in biological sciences or pharmaceutical science. Preferably with clinical laboratory experience.
- Strong understanding of regulatory requirements, GCP, and clinical trial operations.
- Excellent communication and interpersonal skills.
- Ability to analyze complex issues and provide practical solutions.
- Detail-oriented with strong organizational skills.
- Proficiency in Microsoft Office Suite and project management tools.
- Ability to obtain a Public Trust Clearance.
Benefits
FEFA LLC is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. We offer a competitive compensation package including a competitive salary, medical benefits, PTO, holiday pay and more.