Associate Principal QA Specialist

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

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

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 escalating 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.

Requirements / Qualifications:

• BSc or equivalent experience in a scientific subject is preferred, reflecting your strong foundational knowledge.
• Outstanding business and interpersonal skills, with the ability to communicate persuasively in written, oral, and active listening formats to influence peers and colleagues.
• Proven experience in developing and implementing quality assurance plans for technical operations.
• Expertise in conducting quality audits and inspections of technical processes, ensuring flawless compliance.
• Ability to identify and detail non-conformances, initiating corrective actions to maintain strict quality standards.
• Experience in collaborating with technical teams to successfully implement quality improvements, improving overall performance.
• Proficiency in reporting quality metrics and performance indicators, effectively communicating results to collaborators.

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone's ideas, big or small, have the potential to improve millions of lives, and that's the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you're ready to help turn our customers' breakthrough ideas into viable therapies, we look forward to welcoming you on board.