Specialist, Quality Assurance GCP

Clinical Quality Assurance Specialist

The Clinical Quality Assurance Specialist supports the implementation and maintenance of an effective Clinical Quality Management System (QMS) to ensure ICH-GCP compliance for all sponsor-led clinical development activities.

The role provides operational QA support and oversight for clinical trials mainly in Phase II to Phase IV, contributing to inspection readiness, vendor oversight, and continuous improvement of clinical quality processes.

Key Responsibilities

• Support the implementation and maintenance of the Clinical Quality Management System, including SOPs, work instructions, and templates
• Perform clinical quality oversight activities in support of Sponsor responsibilities, including: Study level and system level audits and Vendor and CRO audits and qualifications
• Participate in risk-based quality activities, including quality risk assessments and audit planning
• Support oversight of outsourced clinical activities, ensuring CROs and vendors operate in compliance with ICH GCP and contractual obligations
• Manage and track deviations, CAPAs, and quality issues, supporting root cause analysis and effectiveness checks
• Contribute to inspection readiness activities, including preparation of documentation, mock inspections, and follow up actions
• Support regulatory inspections and audits by health authorities (EMA, FDA, MHRA) as part of the Sponsor QA team
• Provide GCP guidance and quality input to Clinical Operations, Clinical Development, and cross functional teams
• Support the delivery of GCP training and quality awareness initiatives across the organization
• Contribute to continuous improvement initiatives to enhance efficiency, compliance, and quality culture.

Qualifications

• Minimum 4–6 years of experience in Clinical Quality Assurance, Clinical Operations, or related GxP functions.
• Hands on experience supporting Phase II–IV clinical trials.
• Experience working with CROs and external vendors.
• Exposure to regulatory inspections or Sponsor audits is preferred.
• Good knowledge of ICH GCP guidelines and applicable global clinical trial regulations.
• Understanding of sponsor responsibilities in outsourced clinical trial models.
• Familiarity with quality systems, audit processes, and CAPA management.
• Ability to apply a risk-based approach to quality oversight.
• University degree in Life Sciences, Pharmacy, Biology, Chemistry, Medicine, or related discipline.
• Solid understanding of GCP principles and clinical trial processes.
• Strong organizational and time management skills.
• Ability to work effectively in a matrix and cross functional environment.
• Clear and effective written and verbal communication skills in English.
• Problem solving mindset with focus on quality and compliance. Proactive, collaborative, and detail-oriented approach.
• Knowledge of digital tools