QMS & Quality Performance Specialist - #49292

Entity: CSL Vifor

Job Category: Quality

Job Family: Quality Multi Discipline

Job Type: Full Time

Location: St. Gallen, St. Gallen, Switzerland

Employer Reference: R-261672

Job Description

We are currently seeking a QMS & Quality Performance Specialist to join our QA Compliance team in St. Gallen, Switzerland. This position reports directly to the Head of QA Site Compliance.

Responsibilities:

• Drive and support Quality Management System (QMS) harmonization initiatives, contributing to the alignment of quality processes and systems across the organization.
• Independently lead sub-project streams within QMS harmonization projects, coordinating stakeholders, tracking progress, and supporting successful implementation.
• Coordinate, process, and monitor Change Controls and Deviations to ensure timely completion and compliance with applicable requirements.
• Contribute to Quality Performance Management by collecting, tracking and analyzing Key Quality Performance Indicvators (KPIs).
• Prepare quality performance reports, presentations, and management information for CSLV Local & Quality Management Reviews.
• Support the preparation and further development of the monthly CSLV Quality Communication to foster a culture of continuous improvement and collaboration across all CSL departments.

Qualifications:

• Bachelor's degree in Biotechnology, Pharmacy, Chemistry, Biology, Pharma technology or a business-related field.
• 3-5 years of work experience in a GxP environment preferred.
• First experience in Quality Assurance, preferably in the area of Quality Management System (QMS) & Quality Performance Management.
• Basic project management experience would be an asset.
• Strong analytical and problem-solving skills with the ability to collect, consolidate, interpret, and communicate complex data and performance metrics.
• Strong organizational skills, attention to detail, and a structured, solution-oriented working style.
• Fluent English required; German language skills are an advantage.

About CSL Vifor

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/.

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.

You Belong at CSL

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

Equal Opportunity Employer

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.