At a Glance
- Tasks: Lead a team in ensuring quality compliance and managing audits in GMP manufacturing.
- Company: Join Sartorius, a global leader in life sciences making a real impact on health.
- Benefits: Enjoy 29 days annual leave, private medical insurance, and a supportive work culture.
- Other info: Be part of a mission-driven team fighting against diseases like cancer and dementia.
- Why this job: Shape the future of biopharmaceuticals while advancing your career in a dynamic environment.
- Qualifications: Master’s degree in relevant fields and 5+ years in GMP manufacturing required.
The predicted salary is between 50000 - 65000 € per year.
Join our team at our Newhouse facility as Quality Manager. We are looking for a Quality Manager for our Cell Bank Manufacturing department at Sartorius Stedim BioOutsource Ltd. In this role, you will be responsible for managing a team of Quality Assurance and Quality Control Specialists, oversee customer and regulatory audits, be QC named responsible person to maintain our MHRA license, overseeing batch release of GMP batches, work closely with our QP to ensure compliance with regulatory requirements. You will manage a team of 7 and we are looking forward to shaping the future with you. This position is available full time on a permanent basis. It is an onsite role, based at our Newhouse site near Motherwell.
Grow with us – Your Responsibilities
- Maintain and continuously improve our Quality Management System (DotCompliance), monitoring KPIs and reporting to management on a regular basis.
- Approve equipment and facility qualification, validation and maintenance in accordance with appropriate regulatory and usage requirements.
- Assess, inspect (where required) and approve suppliers/contractors to ensure they meet the company’s and Regulatory Authority compliance, technical and service requirements.
- Lead client and Regulatory inspections, and co-ordinate any observations to ensure that they are adequately addressed.
- Prepare and review Quality Agreements with clients defining responsibilities of the Contract Giver and Acceptor in terms of Quality and compliance requirements.
- Review and approve all master batch related documents and co-ordinate release of cell banks with Qualified Person.
- Respond to customer complaints putting in containment actions, full analysis, and implementing short-term and long-term countermeasures.
- Ensure compliance with GMP regulations.
What will convince us
- Master’s degree in Biology, Biopharmaceutical, Biotechnology, Pharmaceutical Manufacturing, Quality or relevant disciplines.
- 5+ years of experience in the pharmaceutical or biotechnology industry ideally in GMP manufacturing environment.
- Experience with sterile manufacturing and batch release would be beneficial.
- Experience of hosting audits (MHRA, FDA).
- Strong leadership skills, experience of managing a team with the ability to build relationships with internal and external stakeholders.
- Experience of maintaining the Quality Management System.
- Excellent communication and presentation skills, as well as strong project management and organisational skills.
- Excellent skills in Microsoft packages such as Word, Excel.
In order to commence working with us, the successful candidate must have the right to work in the UK.
What we offer
- As a growing global life science company, stock listed on the German TecDAX, Sartorius offers a wide range of benefits:
- Personal and Professional Development: Mentoring, leadership programs, internal seminar offerings.
- Making an impact right from the start: Comprehensive onboarding, including a virtual online platform – even before joining.
- Welcoming Culture: Mutual support, team-spirit and international collaboration; communities on numerous topics such as coaching, agile working and businesswomen network.
Benefits
- Attractive Working Conditions.
- 35 hours working week.
- 29 days annual leave, plus 4 public holidays.
- Annual option to buy, sell or carry over annual leave.
- Free parking on site.
- Free hot and cold drinks.
- Regular social events.
- Health & Wellbeing.
- Competitive benefits package, including:
- Private Medical Insurance.
- Private Dental Insurance.
- Group Life Assurance.
- Travel Insurance (Employee Paid).
- Salary Sacrifice Health Assessment Service.
- Salary Sacrifice Cycle to Work Scheme.
Planning Ahead For Your Future
- Group Personal Pension Plan.
- Group Income Protection.
- Salary Sacrifice Will Writing Service.
About Sartorius
Sartorius is part of the solution in the fight against cancer, dementia, and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster, so that new therapeutics can reach patients worldwide. We look for ambitious team players and creative minds, who want to contribute to this goal and advance their careers in a dynamic global environment. Join our global team and become part of the solution. We are looking forward to receiving your application.
Quality Manager - GMP Manufacturing in Glasgow employer: Sartorius Stedim
At Sartorius Stedim BioOutsource Ltd, we pride ourselves on being an excellent employer, offering a supportive and collaborative work culture at our Newhouse facility. With a strong focus on personal and professional development, employees benefit from comprehensive onboarding, mentoring programmes, and a competitive benefits package that includes private medical insurance and generous annual leave. Join us to make a meaningful impact in the life sciences sector while enjoying a healthy work-life balance and opportunities for growth within a dynamic global environment.
StudySmarter Expert Advice🤫
We think this is how you could land Quality Manager - GMP Manufacturing in Glasgow
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend relevant events, and don’t be shy about letting people know you’re on the hunt for a Quality Manager role. You never know who might have the inside scoop on job openings!
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of GMP regulations and quality management systems. We want to see that you can talk the talk and walk the walk when it comes to compliance and quality assurance.
✨Tip Number 3
Showcase your leadership skills! Be ready to discuss how you've managed teams in the past and how you’ve tackled challenges in quality control. We love hearing about real-life examples that demonstrate your ability to lead and inspire.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re genuinely interested in joining our team at Sartorius.
We think you need these skills to ace Quality Manager - GMP Manufacturing in Glasgow
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Quality Manager role. Highlight your experience in GMP manufacturing and any leadership roles you've had. We want to see how your background aligns with what we're looking for!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about quality management and how your skills can help us at Sartorius. Keep it concise but impactful – we love a good story!
Showcase Your Achievements:When detailing your experience, focus on specific achievements rather than just duties. Did you lead a successful audit or improve a process? We want to know how you made a difference in your previous roles!
Apply Through Our Website:Don't forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it’s super easy – just follow the prompts and submit your materials!
How to prepare for a job interview at Sartorius Stedim
✨Know Your GMP Inside Out
Make sure you brush up on your Good Manufacturing Practice (GMP) knowledge. Be ready to discuss how you've implemented GMP in previous roles and how it relates to the responsibilities of a Quality Manager. This will show that you understand the importance of compliance and quality in the manufacturing process.
✨Showcase Your Leadership Skills
As you'll be managing a team of Quality Assurance and Quality Control Specialists, it's crucial to demonstrate your leadership experience. Prepare examples of how you've successfully led teams, resolved conflicts, and built relationships with stakeholders. This will help convince them that you're the right fit for the role.
✨Prepare for Regulatory Audits
Since you'll be overseeing customer and regulatory audits, be prepared to discuss your experience with hosting audits like MHRA or FDA. Think of specific instances where you managed inspections and how you addressed any observations. This will highlight your ability to maintain compliance and handle pressure.
✨Communicate Clearly and Confidently
Excellent communication skills are key for this role. Practice articulating your thoughts clearly and confidently, especially when discussing complex topics like Quality Management Systems or batch release processes. This will not only help you during the interview but also reflect your ability to present information effectively in the workplace.
