Clinical Quality Specialist

Job Summary:

We are seeking a skilled Clinical Quality Specialist with a focus on Quality Management Systems (QMS) to support IDE clinical trials. The ideal candidate will be responsible for establishing, managing, and maintaining QMS processes in compliance with clinical regulatory requirements. This role will ensure that all clinical trials and related activities meet high standards of quality, are GCP-compliant, and that internal and outsourced activities align with established QMS procedures.

Key Responsibilities:

• 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.