We are currently seeking a QA Compliance Manager to join our QA Compliance team in St. Gallen, Switzerland. This position reports directly to the Head of QA Site Compliance.
Responsibilities:
- Own the CSL Vifor Quality Management System (QMS) Framework, ensuring its continuous development, implementation, maintenance, and compliance with corporate quality standards, regulatory requirements, and applicable GxP guidelines.
- Serve as the QA Manager and Single Point of Contact (SPOC) for the enterprise-wide Document and Training Management processes across CSL Vifor.
- Drive and lead QMS harmonization initiatives to standardize and continuously improve quality processes and systems across the organization.
- Independently manage QMS-related projects, coordinating cross-functional stakeholders, monitoring progress, and ensuring successful implementation.
- Provide end-to-end ownership of key Quality and Compliance processes, acting as the primary subject matter expert and business partner for stakeholders across CSL Vifor.
Qualifications:
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, Biochemistry, Biotechnology, or another relevant scientific discipline.
- At least 5 years of experience in Quality Assurance, Quality Management Systems (QMS), and/or Compliance Management, ideally within a GMP-regulated pharmaceutical or biotechnology environment.
- Strong knowledge of Quality Management Systems, cGMP principles, and regulatory compliance requirements.
- Proven stakeholder management skills with the ability to influence, align, and collaborate across functions within a global matrix organization.
- Strong analytical, organizational, and problem-solving skills with a structured and solution-oriented approach.
- Fluent English required; German language skills are an advantage.
Interested in this opportunity? We look forward to receiving your application, including your CV, certifications, and employment references.
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.
