Clinical Quality Assurance Specialist / Expert (GCP)

apartmentgloor&lang AG placeZürich descriptionUnbefristet calendar_month 

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.

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