QA Manager, GCP

About the role

The QA Manager, GCP is responsible for ensuring quality oversight and quality assurance and quality by design activities related to GCP/GCLP area. They guide and support from a quality perspective the GCP/GCLP and GPP related activities within Sobi, including audits, inspections, and support of and risk assessment of the BLA/NDA/IND/CTA submissions under a global umbrella. They also support the collection of data needed for the audit program risk assessment, ensure qualification of global and local ESP, as applicable, in GCP regulated areas per Sobi procedures, and work with relevant stakeholders across the Sobi organization.

Responsibilities

• Ensure GCP Audits management excellence of the end to end audit management process and overview of the assigned audits, as planned
• Assess and approve from quality perspective the GCP deviations (global and local, as applicable), GCP related CAPAs
• Prepare regular status report on performed audits, audit trending, deviation trending, CAPAs trending and agreed upon metrics to ensure Quality oversight
• Contribute and support the GCP audit risk assessment according to SOPs
• Ensure active contribution in the cross-functional team with procurement, business owners for GxP and Quality requirements and documented qualification of GCP service providers and review provisions in contracts/Quality agreements, as applicable
• QA representative during GCP inspections global and site level, as applicable and contribute to the Inspection Readiness framework and promote continuously quality mindset across Sobi
• Authoring GCP QA related processes, review and give guidance under global umbrella

Qualifications

• University degree or similar in Life Sciences or related discipline
• At least 5 years experience from the pharmaceutical industry in Clinical Quality Assurance or in the operational conduct of clinical trials and the application of GCP audit and/or Quality Assurance experience
• Excellent knowhow of the applicable ICH GCP guidelines, industry best practices and FDA, EMA and ROW regulatory requirements
• Quality assurance activities principles and know-how
• Documented education/experience in QA systems and preferably auditing

Technical skills

• Knowledge of applicable ICH GCP guidelines, industry best practices and FDA, EMA and ROW regulatory requirements
• Quality assurance activities principles and know-how
• Documented education/experience in QA systems and preferably auditing

Soft skills

• Structured with focus on results and detail oriented
• Strong interpersonal skills with communicative and flexible attitude
• Proactive and collaborative mindset
• Strong multi-tasking abilities with high resilience at stress and adaptative skills