PpProduct quality and patient safety are at the center of what we do. As part of the Quality Assurance organization, the NPI QA Manager supports new product introductions, technical transfers, and quality oversight activities to ensure compliance with GMP standards, internal procedures, and global regulatory requirements. In close collaboration with cross‑functional stakeholders, this role contributes to the successful and compliant implementation of new products and processes within a highly regulated environment. /p h3Responsibilities /h3 ul liLead and coordinate Quality Assurance activities related to New Product Introduction (NPI) to ensure compliance with company standards and regulatory guidelines. /li liEnsure compliance with established internal specifications, standard operating procedures (SOP) and government regulations. /li liCoordinate and manage complex deviations, task forces and communication to ensure a compliant release system for corresponding market. /li liAct as a key QA contact for interactions with regulatory authorities (Swissmedic, FDA, etc.) to ensure timely product release. /li liSupport submission of test samples, certificates and batch documentation for authorities (Swissmedic, FDA, etc.). /li liProvide technical guidance and recommend improvements to quality systems and processes. /li liInitiate changes to SOPs when a deviation from regulation is identified or a system process is not functional based on the current instructions. /li /ul h3Qualifications /h3 ul liUniversity degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry). /li li7+ years' GMP experience in the pharmaceutical, biotech, or other regulated industry. /li liStrong knowledge of GMP/GQP requirements and regulatory expectations within a regulated manufacturing environment. /li liExperience working within a global matrix organization and collaborating with cross‑functional international stakeholders. /li liExperience supporting product launches, new product introductions (NPI), technical transfers, or manufacturing change activities preferred. /li liFluent English required; German is considered an advantage. /li /ul pDifferent qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable. /p h3Our Benefits /h3 pFor more information on CSL benefits visit How CSL Supports Your Well-being | CSL. /p h3Equal Opportunity Employer /h3 pCSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit /p /p #J-18808-Ljbffr