Product quality and patient safety are at the center of everything we do. The QA Manager Qualification & Validation supports Quality Assurance activities related to manufacturing operations, qualification, validation, and Annex 15 compliance within a highly regulated pharmaceutical/biotech environment. In close collaboration with cross-functional stakeholders, this role helps ensure compliant manufacturing processes, robust quality systems, and continuous GMP compliance.
Responsibilities:
Lead and coordinate Quality Assurance activities in support of manufacturing operations, validation, and qualification processes in accordance with cGMP standards with a focus on Annex 15 changes.
Ensure compliance with established internal specifications, standard operating procedures (SOPs), and government regulations.
Coordinate and manage complex deviations, investigations, and cross-functional task forces to ensure compliant release system for the corresponding market.
Support health authority (Swissmedic, FDA, etc.) interactions and responses related to quality and manufacturing compliance topics to ensure timely product release.
Support submission of test samples, certificates, and batch documentation for authorities as required.
Initiate and maintain SOP revisions and process improvements when gaps, deviations, or compliance risks are identified.
Qualifications:
University degree in a relevant scientific discipline such as Pharmacy, Chemistry, Biology, Biochemistry, or related field
5+ years of GMP experience within pharmaceutical, biotech, or other regulated manufacturing environments.
Strong knowledge of cGMP principles, Annex 15 requirements, and validation/qualification processes.
Experience working within a global matrix organization.
Knowledge of applicable regulatory requirements and health authority expectations.
Fluent English and German required.
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.
