GMP QA Lead — Quality Systems & Compliance Expert

Lonza, Inc.; Slough; On-site; Confidential; Full time

Job summary

Lonza, Inc. is seeking an Associate Principal QA Specialist to provide QA review and oversight across studies and activities, ensuring GMP compliance, regulatory expectations, and global quality standards within QC and Development Services.

This site-based role emphasizes hands-on quality processes and support for Operations. You will lead deviations, CAPAs, change controls, investigations, and OOS records; mentor teams; maintain audit readiness; and drive continuous improvement with

Qualifications

• Experience developing and implementing QA plans for technical operations.
• Proven ability to conduct quality audits and inspections of technical processes.
• Ability to identify non-conformances and initiate corrective actions to maintain quality.

Responsibilities

• 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 GMP knowledge to identify, manage and escalate major and critical compliance issues through the QMS and governance forums.
• Provide QA oversight 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 in cGMP principles, fostering a strong quality culture and continuous compliance mindset.
• Maintain a state of audit readiness through routine area walkthroughs, process audits, inspections, and proactive management of compliance gaps.
• Drive continuous improvement initiatives and quality system enhancements through collaboration with cross-functional teams.

Skills

GMP knowledge

QA oversight

Quality systems

cGMP principles

Mentoring

Audit readiness

Cross-functional collaboration

Education

BSc or equivalent in science

Tools

Quality Management System (QMS)

Job description

Lonza, Inc. is seeking an Associate Principal QA Specialist to provide QA review and oversight across studies and activities, ensuring GMP compliance, regulatory expectations, and global quality standards within QC and Development Services.

This site-based role emphasizes hands-on quality processes and support for Operations. You will lead deviations, CAPAs, change controls, investigations, and OOS records; mentor teams; maintain audit readiness; and drive continuous improvement with