QA Manager, GCP

📋 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.