Product Quality Review (PQR) Coordinator / Author

Innovative and committed to patients worldwide.

CSL Vifor is a global biotechnology leader committed to developing and delivering innovative medicines that improve the lives of patients with serious and rare diseases around the world.

For our Quality Assurance organization, we are looking for a detail-oriented professional to join us in a temporary position until July 31, 2027, as

Product Quality Review (PQR) Coordinator / Author (m/f/d)

In this role, you will review comprehensive Product Quality Reviews (PQRs) received from Contract Manufacturing Organizations (CMOs), coordinate timely input from contributing departments, and author internal PQRs in close collaboration with the QA Lead, ensuring compliance with current Good Manufacturing Practices (cGMP) and applicable regulatory standards.

You will act as a key liaison between Quality Assurance, CMOs, Regulatory Affairs, QC Laboratories, Complaints Management and Supply Chain, gathering, analyzing and documenting critical product quality data to support regulatory compliance and continuous improvement.

Responsibilities

• Document Authoring: Write, format and finalize clear, accurate and compliant Product Quality Review (PQR) reports in close coordination with the QA Lead.
• Data Coordination: Collect and analyze manufacturing data, CMO PQRs, change controls, deviations, out-of-specification (OOS) results and stability data across multiple product sites.
• Cross-Functional Collaboration: Partner with contributing departments and external manufacturing partners to ensure timely input, address data gaps and support the completion of PQR reports.
• Product Quality Trend Analysis: Evaluate statistical trends in product quality and manufacturing processes to identify potential quality issues and opportunities for continuous improvement.
• Compliance Management: Ensure that PQR documentation complies with internal Standard Operating Procedures (SOPs), applicable GMP/GxP requirements and global regulatory expectations.

Qualifications

• Bachelor's degree in Chemistry, Pharmacy, Life Sciences or a related technical discipline.
• At least 2 years of relevant experience in a GMP-regulated environment, preferably within the pharmaceutical, biotechnology or medical device industry.
• Practical experience in technical writing, quality control data review and PQR/APQR compilation.
• Strong working knowledge of GMP regulations, Quality Management Systems (QMS) and data integrity principles.
• Proficiency in analyzing technical data sets and summarizing statistical trends to support product quality assessments.
• Excellent written and spoken English skills; German language skills are an advantage.
• High attention to detail, strong organizational and communication skills, and the ability to manage strict GMP documentation timelines independently.

About this position

• As part of our Quality Assurance organization, you will play an important role in maintaining comprehensive and compliant Product Quality Reviews across CSL Vifor's external manufacturing network.

• Working closely with CMOs and internal stakeholders from Quality Assurance, Regulatory Affairs, QC Laboratories, Complaints Management and Supply Chain, you will contribute to the consistent evaluation and documentation of product quality data while supporting regulatory compliance and continuous improvement.
• This temporary position until July 31, 2027, offers the opportunity to apply your expertise in GMP documentation, quality data analysis and cross-functional coordination within an international pharmaceutical environment.

Interested in this opportunity? We look forward to receiving your application. Please submit your CV, employment references and degree certificates together as one file.

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.