QA Manager, QA Analytics (80-100%)

About the role

The QA Manager, QA Analytics ensures that all QC functional area processes comply with GxP, data integrity and regulatory requirements, acting as the quality and compliance bridge between QC and QA Operations.

Key responsibilities

• Represent QA Analytics in cross‑functional teams and ensure GxP requirements and SOPs are followed.
• Review and approve QC/AD documents such as method transfer, validation, and SOPs.
• Oversee QC deviations/investigations, act as decision‑maker, and drive CAPA closure.
• Support regulatory inspections and customer audits, providing subject‑matter expertise.

Required profile

• Academic degree in Chemistry, Biochemistry, Biotechnology or related Life Science field.
• Extensive experience in pharmaceutical QC/QA, including analytical method validation and change management.
• Strong knowledge of cGMP regulations, USP, European and Japanese Pharmacopeia.
• Auditing experience and interaction with health authorities such as FDA and Swissmedic.
• Excellent written and verbal English; German is a plus.

Required skills

• Analytical method validation
• Deviation and OOx investigation management
• Change management
• cGMP compliance
• Regulatory auditing

What we offer

• Agile career development and dynamic working culture
• Inclusive and ethical workplace
• Compensation programs that recognize high performance
• Comprehensive benefits package (details on Lonza careers site)