Project Manager QC Biosimilars (w/m/d)
Core
Planning, coordinating, and steering projects for implementing biosimilar analytics for active substances, finished pharmaceutical products, and stability studies.
Role type
Senior Project Manager (Quality Control, Biosimilars)
Builds
Biosimilar analytics implementation projects for active substances, finished pharmaceutical products, and stability studies.
Domain
Pharmaceutical industry, Biosimilars, Quality Control
Required skills
Project planning and coordination, Cross-functional stakeholder management, GMP compliance knowledge, Quality risk management, Change control and CAPA management, Audit and inspection coordination, Resource and risk planning, Process improvement.
Preferred skills
Experience with LIMS or eQMS systems, Method transfer and validation experience, Technology transfer experience.
Responsibilities
Create and maintain project plans, milestones, resource and risk plans; Coordinate cross-functional work packages in method transfer, validation, and qualification; Coordinate internal and external partners and service providers; Track change controls, deviations, and CAPAs; Prepare project status reports and management updates; Support audits and regulatory inspections.
Seniority
Senior, hands-on IC
