Related skills
gcp veeva qms sops capa📋 Description
- Develop partnerships with clinical study teams to identify quality risks across studies.
- Ensure QA activities comply by facilitating internal/external GCP audits.
- Foster data integrity and end-to-end quality across programs.
- Identify opportunities for process improvements and CAPA initiatives.
- Lead clinical inspection readiness for assigned programs.
- Support regulatory inspections and draft responses to findings.
🎯 Requirements
- BA/BS degree required; advanced degree a plus.
- 8+ years in biopharma R&D with 6+ years in hands-on GCP QA.
- Experience drafting, reviewing, implementing SOPs.
- Knowledge of global regulations/guidance for GCP, GVP, and CSV/A.
- Direct experience conducting internal/external audits and translating findings into corrective actions.
- Working knowledge of Veeva or similar QMS; inspection management tools a plus.
🎁 Benefits
- Career advancement/development opportunities
- Competitive compensation package
- Bonus eligibility
- 401K + employer contributions
- Generous stock options
- PTO and holidays
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