The role:

The Associate Principal QA Specialist is responsible for providing QA review and oversight across studies and activities, ensuring ongoing compliance with GMP, regulatory expectations, Global Quality Standards, and customer requirements within QC and Development Services. Acting as a GMP Subject Matter Expert (SME), the role implements, manages, and enforces robust quality processes while supporting Operations in maintaining compliance. It also involves managing GMP-related issues through QMS processes, site governance, and senior QA leadership, while promoting a strong culture of quality and continuous improvement. Working closely with senior QA leaders, the position helps identify improvement opportunities, ensures quality processes remain fit for purpose, and maintains high standards of compliance throughout Development Services.

What you will get:

• An agile career and dynamic working culture
• An inclusive and ethical workplace
• Compensation programs that recognize high performance
• A variety of benefits dependant on role and location

The full list of our global benefits can be also found on Employee Benefits | Lonza

This is a fully site‑based role. Working together in person supports close, real‑time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards.

What you will do:

• Provide hands-on QA review, approval, and guidance for deviations, CAPAs, change controls, investigations, and OOS records, ensuring timely, compliant, and risk-based resolution.
• Utilise expert knowledge of GMP and quality systems to identify, manage and escalate major and critical compliance issues through the Quality Management System (QMS) and appropriate governance forums.
• Provide QA oversight and support for QC, MSAT, and Development Services activities, including studies, method validation, reference standards, technology transfer and stability programmes.
• Act as the QA/GMP Subject Matter Expert, providing strategic guidance and quality support to Operations, QC, MSAT, and Development Services.
• Mentor, coach, and develop team members and business partners in cGMP principles, fostering a strong quality culture and continuous compliance mindset.
• Maintain a state of audit readiness through routine area walkthroughs, process audits, support of internal and external inspections, and proactive management of compliance gaps.
• Drive continuous improvement initiatives and quality system enhancements through collaboration with cross-functional teams and quality governance bodies, ensuring processes remain effective, efficient, and fit for purpose.