Apply🧭 Full-Time
💸 105000.0 - 125000.0 USD per year
🔍 Biopharmaceutical
- Bachelor’s degree or equivalent in life sciences or healthcare.
- Over ten years of experience in the pharmaceutical or biotech industry.
- Extensive QA operation experience with GMP/GDP knowledge.
- Strong understanding of regulations, especially Annex 13, APAC, LATAM.
- Fluency in spoken and written English.
- Ability to travel approximately 25% of the time.
- Knowledge of GMP, GDP, and GCP requirements.
- Coordinate a Quality team for IMP compliance.
- Set goals and conduct performance reviews.
- Manage KPIs for QA activities related to IMP suppliers.
- Act as central contact for inquiries, deviations, investigations, and audit observations.
- Ensure compliance with change requests and complaints.
- Maintain all quality agreements and collaborate for adherence.
- Work cross-functionally with internal teams on quality issues.
- Participate in supplier QA meetings to present issues and guide resolutions.
- Review batch records for clinical trials.
- Support supplier audits and ensure readiness for inspections.
Quality Assurance
Posted 3 months ago
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