GMP QA Principal Leader

Lonza; Slough; On-site; Confidential; Full time

Benefits offered by this job

Agile culture

Inclusive workplace

Performance-based compensation

Role-based benefits

Global Lonza benefits

Job summary

Lonza in Slough is seeking an Associate Principal QA Specialist to provide GMP‑driven QA oversight across studies, ensuring compliance with regulatory expectations and Lonza quality standards. The role emphasizes acting as a SME, managing deviations, CAPAs, changes, and investigations while supporting Operations, QC, MSAT, and Development Services.

You will mentor teams, promote a culture of quality, and drive continuous improvement through robust QA processes and timely risk‑based decision

Qualifications

• BSc or equivalent experience in a scientific subject is preferred.
• Experience developing and implementing quality assurance plans for technical operations.
• Expertise in conducting quality audits and inspections of technical processes.
• Ability to identify and detail non-conformances and initiate corrective actions.
• Experience collaborating with technical teams to implement quality improvements.

Responsibilities

• Provide QA review for deviations, CAPAs, change controls, investigations, and OOS records.
• Identify and manage major and critical compliance issues through QMS and governance forums.
• Oversee QA for QC, MSAT, and Development Services activities, including studies and method validation.
• Act as the QA/GMP SME, guiding Operations, QC, MSAT, and Development Services.
• Mentor teams in cGMP principles and foster a strong quality culture.
• Maintain audit readiness through area walkthroughs and internal/external inspections.
• Drive continuous improvement with cross-functional teams and governance bodies.

Skills

GMP Knowledge

Quality Assurance

Quality Audits

CAPA Management

QMS

Regulatory Compliance

Stakeholder Communication

Quality Improvement

Education

BSc in a scientific subject

Tools

QMS systems

Job description

Lonza in Slough is seeking an Associate Principal QA Specialist to provide GMP‑driven QA oversight across studies, ensuring compliance with regulatory expectations and Lonza quality standards. The role emphasizes acting as a SME, managing deviations, CAPAs, changes, and investigations while supporting Operations, QC, MSAT, and Development Services.

You will mentor teams, promote a culture of quality, and drive continuous improvement through robust QA processes and timely risk‑based decision