At a Glance
- Tasks: Lead a team to ensure quality in GMP manufacturing and oversee regulatory compliance.
- Company: Join Sartorius, a global leader in life sciences making a real impact.
- Benefits: Enjoy 29 days annual leave, private health insurance, and a supportive work culture.
- Other info: Collaborative culture with opportunities for personal and professional development.
- 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 - 60000 € 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 employer: Sartorius
Sartorius Stedim BioOutsource Ltd. is an exceptional employer located in Newhouse, Glasgow, offering a vibrant work culture that fosters mutual support and international collaboration. With a strong focus on personal and professional development, employees benefit from comprehensive onboarding, leadership programs, and a competitive benefits package, including private medical insurance and generous annual leave. Join us to make a meaningful impact in the life sciences sector while advancing your career in a dynamic and supportive environment.
StudySmarter Expert Advice🤫
We think this is how you could land Quality Manager - GMP Manufacturing
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend events, and connect on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. Understand their values and how your experience aligns with their goals. This will help you stand out and show that you're genuinely interested in joining the team.
✨Tip Number 3
Practice your answers to common interview questions, but keep it natural. We want you to sound confident and authentic, not like a robot reciting lines. Mock interviews with friends can really help!
✨Tip Number 4
Don’t forget to follow up after your interview! A simple thank-you email can leave a lasting impression and show your enthusiasm for the role. Plus, it keeps you on their radar as they make their decision.
We think you need these skills to ace Quality Manager - GMP Manufacturing
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 relevant leadership roles you've held. 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 in the biopharmaceutical industry. Share specific examples of how you've improved quality systems or led successful audits.
Showcase Your Skills:Don’t forget to highlight your skills in communication, project management, and Microsoft Office. These are key for the Quality Manager position, so make sure we can see them clearly in your application.
Apply Through Our Website:We encourage you to apply through our website for the best chance of getting noticed. It’s super easy, and you’ll be able to keep track of your application status. We can’t wait to hear from you!
How to prepare for a job interview at Sartorius
✨Know Your GMP Inside Out
Make sure you brush up on your Good Manufacturing Practice (GMP) knowledge. Understand the regulations and standards that govern the industry, as well as any recent changes. This will show that you're not just familiar with the basics but are also committed to maintaining high-quality standards.
✨Showcase Your Leadership Skills
As a Quality Manager, you'll be leading a team of specialists. Prepare examples of how you've successfully managed teams in the past, focusing on your leadership style and how you foster collaboration. Be ready to discuss how you handle conflicts and motivate your team.
✨Prepare for Audits and Inspections
Since you'll be overseeing customer and regulatory audits, it's crucial to demonstrate your experience in this area. Think of specific instances where you've led inspections or addressed audit findings. Highlight your ability to maintain compliance and implement corrective actions.
✨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. Consider doing mock interviews with a friend to refine your delivery and ensure you come across as both knowledgeable and approachable.
