Senior QA Specialist, Bioconjugates

About the role

Lonza is looking for a Senior QA Specialist (f/m/d) for its Bioconjugates plant in Visp, Switzerland, within the Biologics Quality organization. The successful candidate will be responsible for QA Bioconjugates activities and will work directly with the Operations Team, MSAT, QA/QC and Project Management teams. Relocation assistance is available for eligible candidates and their families.

Key responsibilities

• Support continuous improvement programs to establish an effective Quality Management System in Bioconjugates.
• Partner with cross-functional teams to identify risks, drive deviation management and continuous improvement.
• Guide stakeholders with QA expertise, ensuring a robust quality culture and operational compliance.
• Manage and take part in the "QA on the floor" program, including QA walkdowns and GEMBA walks.
• Act as QA subject matter expert in meetings, audits and inspections with stakeholders and customers.
• Review and release records such as SOPs, deviations, change requests, effectiveness checks and risk assessments.
• Identify emerging QA topics and develop them into Quality and Compliance strategies and standards, such as CAPAs.
• Train and coach new employees and existing QA specialists.

Required profile

• Degree in Chemistry, Biotechnology, Life Sciences or a related field.
• Extensive experience in the GMP-regulated pharmaceutical industry, including continuous improvement within QA.
• Green Belt certification is an advantage.
• Fluency in English is required; German is an asset.
• Experience interacting with health authorities (Swissmedic, FDA etc.) is desired.
• Experience as a QA trainer is an advantage.

Required skills

• Knowledge of manufacturing processes and of deviations, CAPA and change request management.
• Ability to write, review and approve quality documents such as SOPs.
• Preferred: TrackWise, SAP and Microsoft Office.

What we offer

• An agile career and dynamic working culture in an inclusive, ethical workplace.
• Compensation programs recognizing high performance and benefits depending on role and location.
• Relocation assistance for eligible candidates and their families.