GCP Quality Assurance Specialist, R&D

Position Summary

We are seeking a Senior Specialist, R&D Quality Assurance to support our clinical development programs by ensuring adherence to global GCP standards and regulatory requirements. In this role, you will act as a key Quality Assurance (QA) representative across assigned clinical studies, partnering closely with cross-functional R&D teams. You will also engage with external collaborators—including CROs, laboratories, and other clinical vendors—to foster a culture of quality and compliance throughout all stages of clinical trial execution. This position requires strong subject matter expertise in GCP and the ability to proactively support high-quality, inspection-ready clinical operations.

Key Responsibilities

• Serve as the QA representative on clinical study teams, providing GCP guidance and support.
• Collaborate with external partners (e.g., CROs, labs, vendors) to ensure compliance with applicable global regulations, standards, and internal procedures.
• Act as a quality subject matter expert (SME) for assigned programs and initiatives.
• Support and prepare for Regulatory Authority GCP inspections.
• Contribute to the development and improvement of QA systems, processes, and tools.
• Manage internal QA activities and contribute to the oversight of contract QA personnel and third-party auditors.

Qualifications

Education & Training :

Experience & Skills :

Mostly remote, must come onsite when / as needed.