Position : Clinical Quality Assurance Manager (GCP)
Location: Morrisville, NC (Hybrid/Remote) but need to be in office for Audit
Duration: Contract : 6 Months-Potential to perm)
Our client needs a Clinical Quality Assurance Manager that will be responsible for the maintenance and compliance of the Quality Management System by application of quality principles and Good Clinical Practice (GCP) regulatory requirements. The Clinical Quality Assurance Manager will support key stakeholders of the global operations for clinical services rendered, including management of clinical trials and the patient-enabling solutions group, which encompasses home health solutions, virtual clinical trials, patient concierge services, and patient recruitment. Additionally, the role involves developing, implementing, and maintaining quality assurance standards and processes to ensure the safety, efficacy, and ethical conduct of clinical trials in compliance with GCP.
The Work
Our client needs a mid-level QA professional with 4-5 years of experience in Quality Assurance. The Quality Assurance team encompasses of 13 team members of which half are in the U.S and the other in the U.K. This person will report to the Associate Director and work within the team to develop and implement quality assurance processes and procedures for clinical trials to ensure compliance with GCP guidelines.
Professional Requirements: Hard Skills
- Bachelor's degree or higher (preference for pharmaceutical, life sciences, or nursing)
- Minimum four (4) years of experience in clinical research or quality assurance, with a focus on nursing and/or clinical services.
- Strong understanding of clinical trial methodologies, regulatory requirements, and GCP guidelines.
- Experience in decentralized clinical trials and remote patient monitoring is a plus.
- Proven ability to develop and implement quality assurance systems and processes.
- Auditing, inspection, and vendor management experience
- Regulatory knowledge (e.g., FDA, EMA, GCP), especially ICH GCP and practical application.
- Strong understanding of fundamental principles for core Quality Management System processes (e.g. risk assessments, deviations, change control, supplier/customer management).
- Ability to take a risk-based approach to day-to-day activities.
- IT literate: Microsoft Outlook, Word, Excel is essential.
Responsibilities include:
- Develop, implement, and maintain a comprehensive quality assurance framework for clinical services within remote clinical trials, ensuring adherence to regulatory requirements (e.g., FDA, EMA, GCP) and internal standards.
- Manage relevant quality records and processes (e.g., deviations, change controls, CAPAs, complaints, and other quality incidents).
- Conduct risk assessments to identify potential quality risks associated with nursing and clinical provisions and develop mitigation strategies to minimize their impact.
- Conduct regular audits and inspections of clinical services to assess compliance with quality standards, identify non-conformances, and implement corrective actions.
- Host external client or regulatory inspections, coordinating the audit and relevant responses.
- Monitor, Develop, and/or deliver training programs to staff on quality assurance principles, regulatory requirements, and standard operating procedures.
- Oversee the performance of external clinical and full-service vendors, ensuring they adhere to quality standards and regulatory requirements.
- Monitor data quality and integrity related to clinical activities, ensuring accurate and complete documentation.
- Ensure compliance with all relevant regulatory requirements, including GCP, data privacy regulations (e.g., GDPR), and local laws.
- Ensure adequate resources and capabilities exist within the quality assurance team and that all personnel are trained and developed in line with the requirements of their role.
- Manage personnel, coordinate, and prioritize day-to-day activities as required.
- Lead and coach direct reports driving high operational performance.
- Identify opportunities for process improvement and implement initiatives to enhance the quality and efficiency of clinical services and home health solutions.
- Collaborate with cross-functional teams (e.g., clinical operations, medical affairs, regulatory affairs) to ensure effective communication and alignment on quality standards.
- Analyze and trend quality metrics provided by team members and host the Quality Management Reviews, providing periodic updates to Senior Management.
- Support the validation of all systems (equipment and computer) as required by GxP regulations.
- Point of escalation for clinical quality-related issues inclusive of vendors.
- Key Quality contact point for different projects, delivering Quality actions for project set-up. This includes liaising with clients on deliverables where necessary.