Associate Director - QMS Manager
Job Overview
Associate Director - QMS Manager – Slough
Relocation support and visa sponsorship are available for the successful candidate.
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. The role is fully site‑based and requires close real‑time collaboration to manufacture medicines to the highest quality and safety standards.
What you will do- 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) No536/2014.
- Oversee QP responsibilities specifically related to the confirmation of drug substances and drug substance intermediates, ensuring full regulatory compliance.
- 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, Track Wise 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.
- Qualified Person (QP) status, or active progression toward certification, is highly desirable.
- Fully site‑based role.
- An agile career and dynamic working culture.
- An inclusive and ethical workplace.
- Compensation programs that recognise high performance.
- A variety of benefits depending on role and location.
- Full benefits overview available on Lonza careers website.
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