QA Manufacturing Science Manager

About the role

CSL Vifor, a global pharmaceutical company developing, manufacturing and commercializing therapies for patients with serious and chronic diseases, is strengthening its Quality Assurance organization. As QA Manufacturing Science Manager you will provide strategic QA oversight and technical expertise on analytical method transfers, stability programs, product specifications and Annual Product Quality Reviews (APQRs) for commercial products. You will work closely with Contract Manufacturing Organizations (CMOs), external laboratories and internal stakeholders to ensure GMP compliance, oversee quality-related investigations and support continuous improvement of product quality.

Key responsibilities

• Analytical Method Transfer: compile, review and approve transfer protocols, reports and validation documentation with CMOs, external labs and QC teams
• Stability program: oversee registration and commercial stability, evaluate stability data, investigate OOS and OOT results and ensure shelf-life and storage compliance
• Product specifications: manage and maintain them throughout the commercial lifecycle
• Product Quality Reviews: lead the cross-functional preparation of annual PQRs/APQRs, identify quality trends and recommend CAPAs
• Quality oversight: act as QA SME during regulatory inspections and partner audits, ensuring inspection readiness
• Lifecycle management: assess the quality impact of process changes, deviations and non-conformances and support root cause investigations and CAPAs
• Monitor and support Quality KPIs and promote a strong quality culture

Required profile

• Master's degree or PhD in Chemistry, Pharmacy, Biochemistry, Chemical Engineering, Nanotechnology or a related field
• At least 6 years in pharma or biotech QA/QC, including at least 2 years in a cross-functional role
• Proven experience overseeing external manufacturing partners such as CMOs and external laboratories
• Fluent English; German is an advantage; willingness to travel up to 10%

Required skills

• Strong understanding of analytical chemistry, product quality, stability testing and product specifications, including ICH Q1A(R2)
• In-depth knowledge of global cGMP (FDA, EMA, ICH) and Quality Management Systems (QMS)
• Technical writing, analytical skills and stakeholder management