QC Project Leader 80-100% (m/w/d)

This role is important for ensuring successful technology transfers, maintaining GMP compliance, and driving continuous improvement. The position is based in Visp, Switzerland. Relocation is available for a successful candidate and their family, if needed.

• Manage and lead QC projects from initiation to completion, defining project scope, timelines, resources, deliverables, and reporting project progress while escalating issues when necessary.
• Perform, oversee, and coordinate chemical and physical testing of raw materials, in-process samples, and finished products using analytical techniques such as HPLC, GC, UV/Vis, KF, and FTIR, ensuring data integrity, testing compliance, and timely support of project and release activities.
• Develop, validate, and transfer chromatographic analytical methods in accordance with ICH guidelines, regulatory requirements, and applicable quality standards.
• Troubleshoot analytical instrumentation and methods, implementing corrective and preventive actions as required.
• Ensure compliance with GMP/cGMP requirements, regulatory expectations, and internal quality standards across all QC activities.
• Initiate, manage, and close change controls, deviations, OOS/OOT/OOE investigations, and laboratory investigations, including root cause analysis, impact assessment, CAPA implementation, and thorough documentation to ensure timely resolution.
• Document and review analytical results, project activities, and investigation outcomes in accordance with GMP requirements.
• Prepare, author, review, and approve technical documents, including method validation and method transfer protocols and reports, SOPs, quality instructions, and other QC-related cGMP documentation.
• Act as the primary QC point of contact for assigned customer projects, ensuring effective communication and stakeholder alignment.
• Serve as the interface between QC personnel and external contract laboratories, coordinating testing activities and resolving technical issues as required.
• Collaborate effectively with cross-functional teams, including R&D, Production, Quality Assurance, and external partners, to ensure successful project execution and regulatory compliance.
• Provide technical expertise, coaching, and guidance to junior chemists and other team members.
• Participate in internal and external audits, address audit observations, and support the implementation of continuous improvement initiatives.