Responsibilities: • Under general direction, leads/coordinates Quality Assurance activities in accordance with cGMP standards • Ensures compliance with established internal specifications, standard operating procedures (SOP) and government regulations • Coordinates and manages complex deviations, task forces and communication to ensure compliant release system for corresponding market • Responds to questions from authorities (Swissmedic, FDA, etc.) to ensure timely product release • Supports submission of test samples, certificates and batch documentation for authorities (Swissmedic, FDA, etc.) • Initiates changes to SOPs when a deviation from regulation is identified or a system process is not functional based on the current instructions Qualifications: • University degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry) • 5+ years' GMP experience in pharmaceutical/biotech/or other regulated industry • Experience within a global matrix organization • Knowledge of current Good Manufacturing Practices (cGMP) principles • Knowledge of appropriate regulatory requirements Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.