Quality Manager - Clinical Operations (Remote)

Our client is seeking a highly skilled Quality Manager to ensure the highest standards of quality in clinical trials and processes. The successful candidate will ideally have experience as a Clinical Research Associate (CRA), potentially within a pharmaceutical company or Contract Research Organization (CRO). Responsibilities: Clinical Trial Quality Oversight: Implement, manage, and improve the QMS. Ensure adherence to GCP, SOPs, and regulatory requirements. Oversee data quality and conduct quality control audits. Compliance and Regulatory Management: Monitor and ensure compliance with applicable regulatory standards. Collaborate with regulatory bodies and maintain proper documentation. Process Improvement and Risk Management: Identify risks and develop mitigation strategies. Lead process improvement initiatives and conduct root cause analysis. Training and Development: Develop and deliver training programs. Ensure team members are up-to-date on regulatory changes and quality standards. Collaboration with Key Stakeholders: Work closely with clinical operations, data management, regulatory affairs, and project management teams. Collaborate with external partners to ensure compliance with quality standards. Audit Preparation and Reporting: Prepare for and lead audits. Compile and present audit reports, quality metrics, and compliance findings. Key Skills: Strong knowledge of clinical trial processes, regulatory submissions, data management, and trial monitoring. Excellent analytical and problem-solving skills. Ability to lead and manage multiple projects. Strong communication skills and ability to present complex information clearly. Ability to work collaboratively in a cross-functional team environment. Exceptional leadership and mentorship skills. A proactive approach to quality improvement. Strong organizational and project management capabilities. Flexibility to work in a dynamic environment and handle multiple priorities is essential. Experience as a CRA, ideally in a pharmaceutical company or CRO setting. Familiarity with GCP, ICH guidelines, and regulatory compliance standards. Proven experience in auditing clinical trial sites and implementing corrective actions. Qualifications: Bachelor's degree in Life Sciences, Pharmacy, Nursing, or related field. Advanced degree or equivalent experience in clinical research or pharmaceutical quality management preferred. Minimum of 5 years of experience in clinical research, with a focus on quality assurance or quality management.