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.