CSL Vifor is a global pharmaceutical company dedicated to developing, manufacturing, and commercializing innovative therapies for people living with serious and chronic diseases. We are currently looking for an **NPI QA Manager (100%) - (m/f/d)** at our location in **St. Gallen** who will play a key role in bringing innovative products from development into commercial manufacturing. Working closely with Manufacturing, Regulatory Affairs, Technical Operations and global Quality teams, you will ensure new products and processes are implemented efficiently, compliantly and in line with global GMP standards. **Responsibilities** * Lead and coordinate Quality Assurance activities related to New Product Introduction (NPI) to ensure compliance with company standards and regulatory guidelines. * Ensure compliance with established internal specifications, standard operating procedures (SOP) and government regulations. * Coordinate and manage complex deviations, task forces and communication to ensure compliant release system for corresponding market. * Act as a key QA contact for interactions with regulatory authorities (Swissmedic, FDA, etc.) to ensure timely product release. * Support submission of test samples, certificates and batch documentation for authorities (Swissmedic, FDA, etc.). * Provide technical guidance and recommend improvements to quality systems and processes. * Initiate 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). * 7+ years' GMP experience in the pharmaceutical, biotech, or other regulated industry. * Strong understanding of GMP requirements and quality systems within a regulated pharmaceutical manufacturing environment. * Experience working within a global matrix organization and collaborating with cross-functional international stakeholders. * Experience supporting product launches, new product introductions (NPI), technical transfers, or manufacturing change activities preferred. * Fluent English required; German is considered an advantage. Interested in this opportunity? We look forward to receiving your application, including your CV, employment references, and degree certificates. CSL Vifor is a global partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency and nephrology. We specialize in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision healthcare, aiming to help patients around the world lead better, healthier lives. Headquartered in St. Gallen, Switzerland, CSL Vifor also includes the joint company Vifor Fresenius Medical Care Renal Pharma (with Fresenius Medical Care). The parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people and delivers its lifesaving therapies to people in more than 100 countries. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/. At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging CSL 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 https://www.csl.com/accessibility-statement.