Root cause analysis (RCA) and CAPA implementation for project topics, and general lab topic. Investigation and management of deviations, as Lead Investigator. Quality oversight and audit readiness in GMP-regulated labs (participation in audits for
You will collaborate closely with UCB cross-functional teams supporting pharmacovigilance activities including the Global Pharmacovigilance organization, Affiliate Offices, Clinical Operations, Regulatory Affairs, Commercial teams, etc. Key
You are going to play a key global role in ensuring Quality oversight of Bio MSAT activities across internal and external manufacturing. You will drive quality excellence, support technical transfers and validation, and ensure compliance with evolving
Lead and ensure compliance of global CQA processes across multiple sites; Act as key Quality partner for cross-functional stakeholders (e.g. Clinical Trial Teams, Biometry, CROs); Drive continuous improvement initiatives and proactively identify risks and
The Senior GVP QA Manager is responsible for supporting the maintenance and continuous improvement of the global Pharmacovigilance (PV) System to ensure that Santhera fulfils its legal PV obligations as both a Marketing Authorisation Holder (MAH) and