Clinical Quality Specialist

• Develop, implement, and maintain the Quality Management System (QMS) to ensure compliance with applicable regulations and standards (e.g., ISO 13485, 21 CFR Part 820).

• Ensure QMS procedures are effectively implemented and adhered to across all clinical operations, including those outsourced to CROs ans other vendors.

• Lead internal and external quality audits to assess compliance with QMS requirements and regulatory standards.

• Drive continuous improvement initiatives to enhance QMS processes, ensuring they are scalable and support clinical trial activities.

• Oversee quality assurance activities related to clinical trials to ensure compliance with GCP (Good Clinical Practice) guidelines.

• Manage the review and approval of clinical trial documentation, including protocols, case report forms (CRFs), standard operating procedures (SOPs), and other key documents.

• Work closely with internal teams and external vendors to ensure quality standards are met throughout clinical trials and related processes.

• Conduct quality audits of external partners such as CROs, warehouses, and other vendors to ensure compliance with QMS and GCP requirements.

• Collaborate with external partners to ensure quality standards are maintained and that any non-compliance issues are resolved promptly.

• Establish quality agreements with outsourced vendors and ensure consistent monitoring of their performance.

• Risk Management & CAPA (Corrective and Preventive Actions):

• Identify and assess potential risks related to clinical trial quality, and develop risk management strategies to mitigate these risks.

• Lead investigations of quality issues and manage the implementation of corrective and preventive actions (CAPAs) to address non-conformances.

• Track and report on CAPA effectiveness and follow-up actions to ensure timely resolution.

• Maintain a robust document control system for managing clinical quality-related documents.

• Provide training to internal teams and external partners on QMS procedures, GCP compliance, and clinical quality standards.

 

Qualifications: –

 

• Bachelor’s degree in Life Sciences, Quality Management, Biomedical Engineering, or related field. Certification in Quality Assurance or Clinical Quality (e.g., ASQ Certified Quality Auditor) is preferred.

• 3+ years of experience in clinical quality assurance or quality management in a clinical trial or medical device environment.

• Experience with Quality Management Systems (QMS) implementation, management, and compliance with ISO 13485, 21 CFR Part 820, or similar standards.

• Strong knowledge of GCP (Good Clinical Practice) guidelines and their application in clinical trials.

 

Skills: –

• Expertise in managing and auditing QMS processes and clinical trial quality activities.

• Strong understanding of CAPA processes, risk management, and quality auditing.

• Excellent organizational, problem-solving, and communication skills, with the ability to manage multiple priorities and stakeholders.

• Experience working with outsourced vendors such as CROs, data management, and core labs.