Job Description
📋 Description Hybrid role; reside within commuting distance to San Diego, CA. QA Manager, GCP responsible for QA by design in GCP/GCLP area. Guide and support GCP/GCLP and GPP activities incl audits and inspections. Support data collection for Audit program risk assessment. Support clinical studies from a quality perspective across Sobi. Ensure qualification of ESP in GCP area per Sobi procedures. 🎯 Requirements University degree in Life Sciences or related field. 5+ years in pharma QA or GCP audits in clinical trials. Strong knowledge of ICH GCP, FDA/EMA and ROW requirements. QA system principles and auditing know-how. Documented QA education/experience, auditing preferred. Structured, results-focused with strong interpersonal skills. 🎁 Benefits Hybrid work setup with commuting distance to San Diego. Generous time off policy. Opportunities to attend conferences. Emphasis on work-life balance. Collaborative, team-oriented environment. Chance to contribute to rare disease patient impact.
