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.