QC Project Leader

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.

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

• PhD in Chemistry, Analytical Chemistry, Biochemistry, Chemical Engineering, or a related scientific field; alternatively, a Master's or Bachelor's degree with significant relevant industry experience.

• Strong theoretical and practical expertise in analytical chemistry, including hands-on experience with chromatographic techniques such as HPLC and GC.

• Experience in analytical method development, validation, and transfer is highly desirable.

• Knowledge of GMP requirements and regulatory standards; familiarity with ISO 9001 is considered an advantage.

• Excellent problem-solving and troubleshooting skills, with strong attention to detail and a scientific, data-driven approach.

• Strong organizational, planning, and project management skills, with the ability to manage multiple priorities effectively.

• Strong communication, interpersonal, and leadership skills, with the ability to collaborate effectively across functions and build positive working relationships.

• Team-oriented mindset with a commitment to fostering a positive, collaborative, and professional work environment.

• Fluent in both German and English, with excellent written and verbal communication skills.