Associate Director - QMS Manager

About this role

Responsibilities

• The Associate Director - QMS Manager, will lead the maintenance, development, optimisation, and potential upgrade of the Quality Management System (QMS) and the Good Manufacturing Practice (GMP) training programme at Lonza’s Slough site. This role ensures full alignment with Lonza corporate standards and all applicable regulatory requirements, including US FDA and European guidelines, within a multi‑product GMP biotech contract manufacturing environment. You will provide strategic leadership and direction to the department, supporting both short‑ and long‑term planning, while working closely with site leadership and contributing to global Quality Assurance (QA) GMP systems initiatives across Lonza’s network.
• Qualified Person (QP) status, or active progression toward certification, is highly desirable.
• 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.
• https://www.youtube.com/watch?v=wZaXzPKWEv0&list=PLh3u2rKfWyIfXC2d2O3enUrpMjjJ7DO_x&index=18
• What you will get:
• An agile career and dynamic working culture
• An inclusive and ethical workplace
• Lead the development and continuous improvement of the QMS
• Ensure compliance with GMP regulations and global quality standards
• Monitor QMS performance metrics and drive data-led improvements
• Oversee GMP training programmes and ensure ongoing compliance
• Partner with site leadership to align quality, training and business objectives
• Lead internal audits and support customer and regulatory inspections
• Act as a subject matter expert for quality systems across the site and global network
• Perform the duties of a Qualified Person (QP), when appropriately qualified and required, in accordance with Directive 2001/83/EC, Directive (EU) 2017/1569, and Regulation (EU) No 536/2014.
• Oversee QP responsibilities specifically related to the confirmation of drug substances and drug substance intermediates, ensuring full regulatory compliance.

Requirements

• Degree in a scientific or quality-related discipline
• Strong knowledge of GMP regulations (including FDA, EU, MHRA or PIC/S)
• Experience with quality systems such as Veeva, TrackWise or similar platforms
• Ability to communicate complex information clearly to a range of audiences
• Experience working collaboratively across teams and functions
• A continuous improvement mindset within a regulated environment
• Proven leadership skills, including coaching, mentoring and developing others

About Lonza Group

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. Ready to shape the future of life sciences? Apply now.