Job Summary
A company is looking for a Clinical QA (GCP) Consultant to support global clinical quality assurance activities on a contract basis.
Key Responsibilities:
- Manage quality issues and escalate as necessary
- Plan, execute, and report GCP audits, including site, vendor, and electronic system audits
- Collaborate with cross-functional teams to address quality concerns and support inspection readiness
Required Qualifications:
- Bachelor's degree in life sciences or a related field (advanced degree preferred)
- Experience in GCP Quality Assurance within the pharmaceutical, biotech, or CRO industry
- Proficiency in conducting GCP audits (sites, vendors, systems)
- Strong knowledge of global regulatory requirements (e.g., FDA, EMA, MHRA)
- Ability to work independently and collaboratively in a matrix environment
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