Quality Manager GMP Manufacturing

We are looking for a Quality Manager for our Cell Bank Manufacturing department at Sartorius Stedim BioOutsource 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 arelooking 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 YourResponsibilities

• 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 companys 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

• Masters 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

Asa growing globallife 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 platformeven before joining

• Welcoming Culture: Mutual supportteam-spirit and international collaboration; communities on numerous topics such as coaching agile working and businesswomennetwork

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.
Experience:

Manager