About the job
As the Quality Assurance Manager for Good Clinical Practice (GCP) at Sobi, you will play a pivotal role in ensuring the highest standards of quality oversight, assurance, and design within the GCP/GCLP domains. Your responsibilities will include:
Overseeing quality assurance and design activities related to GCP/GCLP.
Providing guidance and support on GCP/GCLP and GPP-related activities throughout Sobi, including audits, inspections, and risk assessments associated with BLA/NDA/IND/CTA submissions globally.
Facilitating the collection of data necessary for the audit program risk assessment.
Supporting clinical study-related quality activities across Sobi.
Ensuring the qualification of global and local ESP in GCP regulated areas according to Sobi procedures.
Collaborating with relevant stakeholders across the Sobi organization.
Key Responsibilities:
Manage the GCP audit process to ensure excellence throughout the audit lifecycle.
Assess and approve GCP deviations and related CAPAs from a quality perspective.
Prepare regular status reports on audits, trending deviations, and CAPAs to uphold quality oversight.
Contribute to GCP audit risk assessments according to SOPs.
Actively engage with cross-functional teams on GxP and Quality requirements, ensuring proper qualification of GCP service providers.
Serve as the QA representative during GCP inspections and promote a continuous quality mindset across Sobi.
Develop and review GCP QA-related processes under the global framework.
