At a Glance
- Tasks: Lead and optimise the Quality Management System in a biotech environment.
- Company: Join Lonza, a leader in biotech with a commitment to quality and innovation.
- Benefits: Agile career opportunities, competitive compensation, and a dynamic work culture.
- Other info: Relocation support and visa sponsorship available for the right candidate.
- Why this job: Make a real impact on medicine quality and safety while leading a talented team.
- Qualifications: Degree in a scientific field and strong GMP knowledge required.
The predicted salary is between 60000 - 80000 £ per year.
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.
What we are looking for:
- 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.
Requirements:
- Qualified Person (QP) status, or active progression toward certification, is highly desirable.
- Fully site‑based role.
What you will get:
- 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.
Associate Director - QMS Manager in Slough employer: Lonza Group Ltd.
At Lonza's Slough site, we pride ourselves on being an excellent employer, offering a dynamic working culture that fosters inclusivity and ethical practices. Our commitment to employee growth is evident through comprehensive training programmes and leadership opportunities, ensuring that our team members can thrive in their careers while contributing to the highest standards of quality in biotech manufacturing. With relocation support and visa sponsorship available, we welcome talent from diverse backgrounds to join us in making a meaningful impact in the healthcare sector.
StudySmarter Expert Advice🤫
We think this is how you could land Associate Director - QMS Manager in Slough
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We think you need these skills to ace Associate Director - QMS Manager in Slough
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Lonza Group Ltd.!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Lonza Group Ltd. that you're not just a fit for the job but also a safety-conscious candidate!
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How to prepare for a job interview at Lonza Group Ltd.
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Lonza Group Ltd. that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
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If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Lonza Group Ltd.’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
