Product quality and patient safety are at the center of what we do. The QA Manager Production & eBR is responsible for leading Quality Assurance activities within a production-focused GMP environment, supporting manufacturing operations, electronic batch record (paper-on-glass) processes, and compliant product release activities. This role plays a key part in ensuring operational excellence, driving continuous improvement, and supporting stakeholders through a critical transformation and hypercare phase within a highly regulated pharmaceutical/biotech environment.
Responsibilities:
Lead and coordinate Quality Assurance activities within a GMP-regulated production environment to ensure compliance with internal standards and regulatory requirements.
Provide QA oversight for electronic batch record (eBR/paper-on-glass) processes and support compliant manufacturing and batch release activities.
Act as a key QA partner for Production and cross-functional stakeholders during process implementation and continuous improvement initiatives.
Coordinate and manage complex deviations, investigations, CAPAs, and cross-functional task forces to ensure timely resolution and ongoing GMP compliance.
Ensure compliance with established internal specifications, standard operating procedures (SOPs), and government regulations.
Support inspection readiness activities and interactions with regulatory authorities such as Swissmedic and FDA.
Review and approve GMP documentation, batch records, and quality-related manufacturing documentation.
Initiate and support process improvements, SOP updates, and quality system enhancements to maintain operational efficiency and regulatory compliance.
Qualifications:
University degree in a relevant scientific discipline such as Pharmacy, Chemistry, Biology, Biochemistry, or a related field.
7+ years of GMP experience within the pharmaceutical, biotech, or other highly regulated manufacturing environment.
Solid knowledge of current Good Manufacturing Practices (cGMP), Good Quality Practices (GQP) and applicable regulatory requirements.
Experience working within a global matrix organization and collaborating with cross-functional stakeholders.
Experience with electronic batch record (eBR/paper-on-glass) systems or digital manufacturing environments preferred.
Fluent German and English 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.
