Senior QA Project Lead — Biotech Manufacturing

Lonza; Schweiz; On-site; Vertraulich; Full time

Benefits offered by this job

Agile culture

Inclusive workplace

Performance rewards

Benefits vary by role

Job summary

Lonza in Visp, Switzerland, is seeking a Senior QA Specialist for QA Projects to define quality requirements across biopharma manufacturing life cycles and ensure cGMP compliance in cross-functional teams.

You will own quality responsibilities for manufacturing processes, review records, and assess changes with change controls for regulatory filings where required, ensuring product safety and quality. This role is based in Visp and supports commercial and clinical supply.

Responsibilities

• Own all quality related responsibilities for the manufacturing processes of biopharmaceutical products for clinical and commercial supply. Represent QA in project/tech transfer organizations for new biotech manufacturing processes.
• Responsible for review and final release of records like SOPs, Master Manufacturing Batch Records, Material Specifications, Deviations, Change Requests, Effectiveness Checks, Testing Protocols & Reports etc.
• Perform assessments for all product-related changes, assess relevance to regulatory filings, decide to implement and provide change controls for approval to customers where required.

Job description

Lonza in Visp, Switzerland, is seeking a Senior QA Specialist for QA Projects to define quality requirements across biopharma manufacturing life cycles and ensure cGMP compliance in cross-functional teams.

You will own quality responsibilities for manufacturing processes, review records, and assess changes with change controls for regulatory filings where required, ensuring product safety and quality. This role is based in Visp and supports commercial and clinical supply.