QA Manufacturing Science Lead — Method Transfer & Stability

CSL; Sankt Gallen; Remote; CHF 140,000 - 180,000; Full time

Job summary

CSL Vifor is seeking an experienced QA Manufacturing Science Manager to provide strategic Quality Assurance oversight for analytical method transfers, stability programs and product specifications. You will collaborate with CMOs, external labs and internal stakeholders to ensure GMP compliance and drive continuous improvement across the commercial lifecycle.

The role emphasizes cross-functional leadership in PQR/APR processes, CAPA implementation and regulatory readiness, with responsibility for

Qualifications

• Master's or PhD in a scientific field with relevant QA experience.
• Proven track record in QA oversight of CMOs/labs and regulatory audits.
• Experience interpreting ICH and cGMP guidelines and applying them to product quality reviews.

Responsibilities

• Provide strategic QA oversight across analytical method transfers, stability programs, and product specifications.
• Lead PQR/APR preparation and CAPA-driven continuous improvement.
• Ensure inspection readiness and regulatory compliance during audits and inspections.
• Oversee lifecycle management of manufacturing changes, deviations and OOS events.

Skills

Quality assurance

Regulatory compliance

Analytical chemistry

Cross-functional collaboration

Technical writing

Education

Master's degree in Chemistry/Pharmacy

Tools

QMS systems

LIMS

Job description

CSL Vifor is seeking an experienced QA Manufacturing Science Manager to provide strategic Quality Assurance oversight for analytical method transfers, stability programs and product specifications. You will collaborate with CMOs, external labs and internal stakeholders to ensure GMP compliance and drive continuous improvement across the commercial lifecycle.

The role emphasizes cross-functional leadership in PQR/APR processes, CAPA implementation and regulatory readiness, with responsibility for