Senior QA Specialist – QA Projects

About the role

The Senior QA Specialist will define quality requirements for manufacturing processes and cGMP standards throughout their life cycle, acting as the Quality and Compliance representative in cross‑functional project teams.

Key responsibilities

• Own quality responsibilities for biopharmaceutical manufacturing processes for clinical and commercial supply.
• Represent QA in project and tech‑transfer organizations for new biotech manufacturing processes.
• Review and release SOPs, batch records, material specifications, deviations, change requests, testing protocols and reports.
• Assess product‑related changes for regulatory impact and manage change controls.
• Investigate deviations and customer product complaints, ensuring proper documentation.

Required profile

• Academic degree in Chemistry, Biotechnology, Life Science or related field.
• Solid experience in GMP‑regulated pharmaceutical industry, preferably in a QA role.
• Knowledge of biopharmaceutical manufacturing processes and analytical methods.
• Experience interacting with health authorities such as Swissmedic and FDA.
• Strong organizational skills, ability to prioritize, and excellent communication in English.

Required skills

• GMP / cGMP compliance
• SOP and batch record management
• Deviation investigation and change control
• Regulatory filing assessment
• Interaction with health authorities (Swissmedic, FDA)

What we offer

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