Senior QA Manufacturing Science Lead

CSL; Zürich; Hybrid; CHF 140,000 - 190,000; Full time

Job summary

CSL Vifor is seeking an experienced QA Manufacturing Science Manager to provide strategic QA oversight across analytical method transfers, stability programs and product specifications for commercial products. You will collaborate with CMOs, external labs and internal stakeholders to ensure GMP compliance and timely, compliant documentation.

The role emphasizes cross-functional leadership, lifecycle management, CAPA driven continuous improvement, and inspection readiness across global regulatory

Qualifications

• Master's or PhD in a relevant chemical/biomedical field.
• 6+ years in pharma/biotech with QA/QC, incl. cross-functional work.
• Experience with oversight of external manufacturing partners (CMOs) and labs.
• Strong knowledge of analytical chemistry, stability testing and product specs; ICH Q1A guidance familiarity.

Responsibilities

• Provide strategic QA oversight for analytical method transfers, stability programs, product specifications and APQRs.
• Lead QA oversight during inspections and audits of CMOs and external labs.
• Manage lifecycle changes, deviations, OOS/OOT events and CAPA implementation.

Skills

QA oversight

External CMOs management

Analytical chemistry

Stability testing

PQR/APQRs

GMP compliance

Regulatory inspections

cGMP regulations

Documentation

Education

Master's degree or PhD in Chemistry/Pharmacy/Biochemistry/Chemical Engineering/Nanotechnology

Tools

QMS software

Regulatory guidelines (ICH Q1A)

Job description

CSL Vifor is seeking an experienced QA Manufacturing Science Manager to provide strategic QA oversight across analytical method transfers, stability programs and product specifications for commercial products. You will collaborate with CMOs, external labs and internal stakeholders to ensure GMP compliance and timely, compliant documentation.

The role emphasizes cross-functional leadership, lifecycle management, CAPA driven continuous improvement, and inspection readiness across global regulatory