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gcp audit ich qms capa📋 Description
- Assist CQA leadership with audit plan development for clinical programs
- Oversee GCP audits of sites, vendors, TMFs, and study docs
- Represent CQA at clinical study team and related meetings
- Guide clinical functions to ensure GCP compliance of data and docs
- Facilitate investigations of quality events and CAPA risk mitigation
- Develop and maintain QA procedures and governance standards
🎯 Requirements
- Bachelor's degree in biological sciences or equivalent
- 8-10 years QA experience in biopharma with increasing responsibilities
- Minimum 6 years direct GCP audit experience
- In-depth knowledge of GCP regulations (FDA, EMA, ICH)
- Experience with electronic QMS to monitor tasks and KPIs
- Strong communication and problem-solving skills
🎁 Benefits
- Competitive compensation and benefits package
- Base salary, performance bonus, equity, health and retirement benefits
- Three weeks PTO, two company shutdowns and paid sick leave
- Professional development opportunities
- Regular all-team in-person meetings to build relationships
- Equal opportunity employer
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