Qa manufacturing science manager

Innovative and committed to patients worldwide.

CSL Vifor is a global pharmaceutical company dedicated to developing, manufacturing and commercializing innovative therapies for patients with serious and chronic diseases.

To strengthen our Quality Assurance organization, we are looking for an experienced professional to join us as

QA Manufacturing Science Manager (m/f/d)

In this role, you will provide strategic Quality Assurance oversight and technical expertise across analytical method transfers, stability programs, product specifications and Annual Product Quality Reviews (APQRs) for CSL Vifor's commercial products.

Working closely with Contract Manufacturing Organizations (CMOs), external laboratories and internal stakeholders, you will ensure GMP compliance, oversee quality-related investigations and support the continuous improvement of product quality throughout the commercial lifecycle. You will combine strong technical knowledge with a Quality Assurance mindset to ensure the quality and regulatory compliance of our products and external manufacturing partners.

Responsibilities

• Analytical Method Transfer (AMT): Compile, review and approve analytical method transfer protocols, reports and validation documentation, collaborating with CMOs, external laboratories and QC teams to ensure the successful transfer and implementation of analytical methods across different sites.
• Stability Program Management: Oversee registration and commercial stability programs, evaluate stability data, investigate out-of-specification (OOS) and out-of-trend (OOT) results, and ensure regulatory compliance with product shelf-life and storage requirements.
• Product Specification Management: Manage and maintain product specifications throughout the commercial product lifecycle, ensuring alignment with applicable quality and regulatory requirements.
• Product Quality Reviews (PQRs): Lead the cross-functional compilation, analysis and preparation of annual Product Quality Reviews (PQRs/APRs), identifying quality trends, evaluating process consistency and recommending corrective and preventive actions (CAPAs) to drive continuous improvement.
• Quality Oversight: Act as a Quality Assurance subject matter expert (SME) during regulatory inspections and external partner audits relating to analytical method transfers, stability programs and PQR data, ensuring inspection readiness and timely, compliant documentation.
• Lifecycle Management: Assess the quality and compliance impact of manufacturing process changes, deviations, non-conformances and OOS events, supporting root cause investigations and the implementation of effective CAPAs.
• Quality Performance: Monitor and support the achievement of Quality KPIs, promoting continuous improvement and a strong quality culture across internal teams and external manufacturing partners.

Qualifications

• Master's degree or PhD in Chemistry, Pharmacy, Biochemistry, Chemical Engineering, Nanotechnology or a related scientific discipline.
• At least 6 years of experience in the pharmaceutical or biotechnology industry across Quality Assurance and Quality Control functions, including at least 2 years in a cross-functional role.
• Proven experience in Quality Assurance oversight and management of external manufacturing partners, including CMOs and external laboratories.
• Strong technical understanding of analytical chemistry, product quality, stability testing and product specifications, including knowledge of ICH Q1A(R2) guidelines and interpretation of quality data for PQRs.
• In-depth knowledge of global cGMP regulations (FDA, EMA, ICH) and proficiency in Quality Management Systems (QMS).
• Excellent technical writing and analytical skills, with the ability to interpret complex scientific data and communicate findings clearly to technical and non-technical stakeholders.
• Strong stakeholder management, communication and influencing skills, with demonstrated ability to collaborate effectively across functions and manage relationships with external partners.
• Highly organized, adaptable and solution-oriented approach, with the ability to manage competing priorities, meet deadlines and respond to changing business needs.
• Fluent English, both written and spoken; German language skills are an advantage.
• Willingness to travel up to 10%.

About this position

As part of our Quality Assurance organization, you will play a key role in maintaining the quality and regulatory compliance of CSL Vifor products throughout their commercial lifecycle. Working at the interface between Quality Assurance, Quality Control, Technical Operations and external manufacturing partners, you will combine scientific expertise with a strong QA mindset to support analytical method transfers, stability programs, product specifications and ongoing product quality oversight. The position offers a diverse and technically challenging scope, combining routine GMP responsibilities with cross-functional projects and continuous improvement initiatives. You will collaborate with a broad network of internal and external stakeholders while contributing to the consistent quality, safety and regulatory compliance of our products.

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.