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.
www.sartorius.com/careers
Skills Required
- 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
- Experience of hosting audits (MHRA, FDA)
- Strong leadership skills, experience of managing a team
- Experience of maintaining the Quality Management System
- Excellent communication and presentation skills
- Excellent skills in Microsoft packages such as Word, Excel
Sartorius Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Sartorius and has not been reviewed or approved by Sartorius.
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Healthcare Strength — Health coverage includes multiple medical plan options with dental, vision, HSA/FSA, EAP, and wellness resources across many locations. Quality of core medical, dental, and vision is characterized as solid.
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Retirement Support — Retirement offerings include a 401(k) with a company match highlighted in U.S. materials and employer‑verified listings. The match is characterized as generous at some sites.
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Flexible Benefits — Flexible hours and hybrid/home‑office options are available where roles and regions allow, with role‑dependent perks in some locations. Broader extras such as commuter benefits, discounts, and tuition assistance add optionality where eligible.
Sartorius Insights
What We Do
Sartorius is a leading international partner of life sciences research and biopharmaceutical manufacturing. We help our customers #SimplifyProgress from drug discovery to manufacturing so that more people can have access to better medicine. With this, we are #PartOfTheSolution in the fight against diseases worldwide. With innovative laboratory instruments and consumables, the our Lab Products & Services division focuses on laboratories performing research and quality control at pharmaceutical and biopharmaceutical companies as well as academic research institutes. The Bioprocess Solutions division, with its broad product portfolio focusing on single-use solutions, helps customers manufacture biotech medications, vaccines, and cell and gene therapies safely, rapidly, and economically. Based in Göttingen, Germany, Sartorius also has a strong global reach with around 60 production and sales sites worldwide. We regularly expand our portfolio through the acquisition of complementary technologies. In 2023, Sartorius generated sales revenue of around 3.4 billion euros. Currently, around 14,600 employees from around 110 nations are working for customers around the globe. Join our team, partner or collaborate with us.
