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, free drinks, and a supportive work culture.
- Other info: Be part of a mission-driven team fighting against diseases like cancer.
- 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
- 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.
- 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: Dormont Manufacturing Co
At Sartorius Stedim BioOutsource Ltd, we pride ourselves on being an exceptional 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, including generous annual leave and health initiatives. Join us to make a meaningful impact in the life sciences sector while advancing your career in a dynamic and innovative environment.
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