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

Job Responsibilities:

• 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.

Job Qualifications:

• 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.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.