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.