Manager, Clinical Program Documentation Control and Audit Readiness at Biogen Poland

Biogen Poland is hiring a Manager of Clinical Program Documentation Control and Audit Readiness to lead audit readiness, inspection support, documentation control, evidence response, and CPSC documentation standards. The role coordinates procurement records across R&D Quality, Internal Audit, Legal, Regulatory, Trial Master File, Vendor Management, and Clinical Study teams; develops SOPs, templates, playbooks, governance models, and training materials; and drives continuous improvement. It requires a bachelor’s degree, at least five years of relevant experience, strong project management and communication skills, and the ability to lead cross-functional stakeholders. The position is hybrid, requires occasional flexibility for global regulatory events, and requires a work permit and residency in Poland.