Clinical Quality Assurance Specialist / Expert (GCP)

Region Zug – Zürich | Hybrid

For a growing biopharmaceutical development organization in the Zug–Zurich region, we are looking for a Clinical Quality Assurance Specialist / Expert to support the quality oversight of clinical development programs.

This role is suited for early to mid-career professionals with experience in clinical trials and GCP-based quality environments. It is a hands-on specialist role without management responsibility.

Responsibilities

• Support clinical quality oversight of clinical trials
• Review clinical study documentation and processes
• Contribute to Trial Master File (TMF) quality and documentation management
• Support GCP compliance across clinical programs
• Conduct quality reviews and checks of clinical documentation
• Collaborate with Clinical Operations, QA, and external partners (e.g. CROs)

Profile

• Degree in Life Sciences (BSc or MSc)
• Approx. 3–7 years of experience in pharma, biotech, CRO, or clinical research
• Experience in Clinical QA, Clinical Operations, or clinical study environments
• Good understanding of GCP and clinical trial documentation
• Structured, pragmatic working style
• Fluent English

Backgrounds of interest

• Clinical QA professionals in pharma or biotech
• Clinical Operations professionals with QA exposure
• CRO professionals with experience in study quality, GCP compliance, and documentation
• QA specialists with experience in clinical trial oversight or TMF management
• Professionals from clinical study sites with strong experience in study documentation and regulatory requirements

Help shape the future of biosimilars!
Join a growing clinical development organization with a dynamic, start-up-like environment and contribute to the quality and compliance of international clinical trials.