Product 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.
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 knowledge of GMP/GQP requirements and regulatory expectations within a regulated 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.
Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.
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.
