QA Manager, GCP

📋 Description

• Oversee quality oversight and quality by design activities related to GCP/GCLP
• Provide quality guidance for GCP/GCLP and GPP-related activities, including audits and risk
• Support data collection for Audit program risk assessment
• Support quality perspectives across clinical studies-related activities
• Ensure qualification of ESP in GCP-regulated areas per Sobi procedures
• Collaborate with stakeholders across Sobi organization to maintain quality standards

🎯 Requirements

• University degree or equivalent in Life Sciences or related field
• 5+ years in pharmaceutical industry QA, Clinical Quality Assurance, or GCP audit/QA of clinical
• Strong knowledge of ICH GCP, regulatory requirements (FDA/EMA/ROW)
• QA principles, auditing experience, and QA systems knowledge
• Documented QA education/experience; auditing experience preferred
• Structured, results-focused with strong interpersonal and collaborative skills

🎁 Benefits

• Competitive compensation and total rewards
• Generous time off and work-life balance emphasis
• Opportunity to attend conferences and develop professionally
• Global team with diverse, inclusive culture