StellenbeschreibungppLocation: Stein, AG, Switzerland. Relocation assistance is available for eligible candidates and their families. /p pThe role is based primarily at the site; you will work onsite to support close, real‑time collaboration required for manufacturing medicines to the highest quality and safety standards. Flexibility to work remotely is available for no more than 20% of your time, considered on a case‑by‑case basis. /p pJob Summary: As Project Lead Quality Control, you will act as the primary QC contact for customers, assessing laboratory capacity, coordinating analytical method transfers, and ensuring successful implementation of release and stability testing for late‑phase and commercial biologics. You will collaborate closely with Program Managers and cross‑functional teams to drive QC project execution, manage timelines, provide scientific guidance on testing strategies, and ensure regulatory and GMP‑compliant delivery of project milestones. /p h3Responsibilities /h3 ul liLead and coordinate QC related project activities for release and stability testing of late‑phase (PPQ) and commercial drug products, focusing on large molecules and antibody drug conjugates (ADCs). /li liServe as the primary QC representative and project champion, driving project execution through effective coordination of timelines, deliverables, customer engagements, and stakeholder communication in partnership with Program Managers. /li liAssess laboratory capacity and manage analytical method transfers, ensuring timely implementation of testing to meet customer and project requirements. /li liImplement analytical testing strategies, including method suitability assessments, performance evaluation, control strategies, and specification setting. /li liAuthor quality records and cGMP documents such as procedures (SOPs), source documents, reports, deviations, and change requests. /li liAct as QC subject matter expert during audits, inspections, and customer meetings while ensuring GMP‑compliant documentation and regulatory readiness. /li /ul h3Qualifications /h3 ul liExperience in a GMP‑regulated pharmaceutical quality control environment with a strong understanding of analytical testing of biologics (large molecules) is required. /li liStrong collaboration and stakeholder management skills, confidence to coordinate activities, provide constructive challenge, and interact effectively with customers and internal teams. /li liExperience in project coordination, analytical method validation and/or method transfer is a strong advantage. /li liFluency in English is required; fluency in German is a plus. /li liDegree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or a related life sciences discipline. /li /ul h3Benefits /h3 ul liAn agile career and a dynamic work culture. /li liAn inclusive and ethical workplace. /li liCompensation programs that recognize high performance. /li liCompetitive salary plus numerous lifestyle, family, and leisure benefits. /li /ul /p #J-18808-Ljbffr