Senior Laboratory Operations Analyst (Senior QC Analyst) Position Overview Helsinn Birex Pharmaceuticals is currently seeking a Senior QC Analyst to join our Laboratory Operations team. This role offers the opportunity to take a hands-on leadership position within a dynamic and regulated environment. The successful candidate will be responsible for the supervision and development of QC Analysts, review and approval of analytical data, and coordination of laboratory schedules, ensuring compliance with cGMP and cGLP standards. This position plays a key role in supporting the sites quality control operations and maintaining inspection readiness. Key Responsibilities Provide leadership, training, and direction to QC Analysts and apprentices. Develop and coordinate weekly work schedules and ensure effective task delegation. Review analyst documentation to ensure accuracy and adherence to Right First Time KPIs. Perform and oversee raw material, in-process, and finished product testing (chemistry and microbiology). Monitor trends and prepare monthly/annual reports for management. Maintain and review laboratory SOPs, specifications, and training records. Lead or support investigations, deviations, and change controls within the QC area. Troubleshoot analytical issues and provide technical support to other departments. Support audit preparation activities and participate in internal/external audits (HPRA/FDA). Represent QC on cross-functional projects and support equipment qualification/validation. Required Qualifications and Experience BSc in a relevant scientific discipline (required). 34 years of experience in a cGLP environment, ideally in HPRA/FDA-approved facilities. 12 years of experience in people management or team supervision in a laboratory setting (preferred). Expertise in HPLC and GC methods (SME-level preferred). Strong data review and documentation skills with high attention to detail. Demonstrated ability to manage workload and meet deadlines in a regulated environment. Experience with regulatory audits and implementing corrective actions. Proficiency with systems such as LIMS Sample Manager, Chromeleon, E09, and Trackwise Digital. Key Competencies Strong leadership and mentoring abilities. Excellent planning, organisational, and time management skills. High level of technical and analytical problem-solving capabilities. Clear and professional communication skills, both verbal and written. Ability to work collaboratively across departments. Commitment to quality, continuous improvement, and compliance. Proactive attitude with the ability to take initiative and make decisions. Strong sense of accountability and ownership. Helsinn Birex Pharmaceuticals - we are a global pharmaceutical company and a leader in supportive care focused on improving the health and quality of life of patients with cancer and chronic diseases. For more information, please visit our company website ( Skills: GLP GMP HPLC Dissolutions GC Benefits: Performance Bonus Parking Space with EV Charger Health Insurance Flex Time Subsidized Canteen Pension Scheme