QA Manager, GCP

The QA Manager, GCP is responsible for:  

• Ensuring quality oversight and quality assurance and quality by design activities related to GCP/GCLP area 

• Guide and support from a quality perspective the GCP/GCLP and GPP related activities within Sobi, including audits, inspection and support of and risk assessment of the BLA/NDA/IND/CTA submissions under global umbrella. 

• Support the collection of the data needed for Audit program risk assessment 

• Support from quality perspective the clinical studies related activities across Sobi  

• Ensure qualification of global and local ESP, as applicable, in GCP regulated area per Sobi procedures 

• The employee will in this role work with relevant stakeholders across the Sobi organization. 

Key responsibilities:

• Ensure GCP Audits management excellence of the end to end audit management process and overview of the assigned audits, as planned 

• Asses 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 ternding,  CAPAs trending and agreed upon metrics to ensure Quality oversight.  

• Contributeand support the GCP audit risk assesment 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.