Clinical Quality Assurance (CQA) Manager

Job description

Overview The Clinical Quality Assurance (CQA) Manager plays a key role in ensuring that all clinical trial activities are conducted in compliance with global regulatory requirements, Good Clinical Practice (GCP) guidelines, and internal quality standards. This position supports the development, execution, and continuous improvement of the company’s clinical quality system, helping to safeguard patient safety, data integrity, and regulatory readiness across all clinical programs. In addition to core GCP responsibilities, this role provides quality oversight of clinical labeling processes, human factors activities and where required non-clinical activities. This role is critical in ensuring compliance with global regulatory standards, maintaining relevant related quality standards, and fostering strong partnerships with internal and external clinical development teams, device development, labeling and non-clinical partners. Responsibilities: - Assist in the development, review, and maintenance of quality documents, including SOPs, work instructions, quality agreements, and quality plans.• Support the planning, execution, and follow‑up of GCP& GLP audits, including investigator sites,...