Manager of Virus Clearance Services UK

The Manager will be responsible for overseeing the conduct of GLP operations in Confidence Virus Clearance Services UK. They will ensure that a sufficient number of qualified personnel appropriate facilities equipment and materials are available for the timely and proper conduct of regulatory studies.

We are looking for a Manager of Virus Clearance Services UK for the Confidence Virus Clearance Team at Sartorius Stedim this role you will be responsible for managing the test facility of Maxim Park to ensure compliance with regulatory requirements (GLP). You will oversee all of the regulatory work that is conducted on site and allocate resources to GLP studies review documentation quality management system and oversight of the commercial aspects of managing the facility. Part of the role is to attend customer meetings and provide technical support relating to viral safety of biopharmaceutical products.

The site consists of a team of 19 professionals with 6 direct reports and we arelooking forward to shaping the future with you.

This position is available full-time based at our site in Maxim Park Eurocentral with some hybrid working available.

Grow with us YourResponsibilities

• Lead and manage GLP-compliant operations for Confidence Virus Clearance UK ensuring appropriate staffing facilities equipment and materials are in place to deliver regulatory studies effectively and on time.

• Provide line management and leadership to a team of 6 direct reports ensuring team capability training development and accurate records of qualifications and experience are maintained.

• Oversee the planning and execution of GLP studies including resource allocation coordination with Study Directors and Principal Investigators and ensuring study plans amendments and master schedules are properly approved and maintained.

• Ensure full regulatory compliance with GLP standards and relevant guidelines (e.g. ICH Q5A GLP SI 3106 OECD) including maintaining organisation structure documentation and clear communication across multi-site studies where applicable.

• Own and maintain quality systems and assurance programmes including SOP approval deviations change controls audits and ensuring Quality Assurance activities are performed in line with GLP principles.

• Act as the site lead for inspections and audits hosting regulatory (e.g. MHRA FDA) and customer inspections and acting as a named individual on the operator licence where required.

• Ensure operational and commercial oversight of the facility including supplier and test site approval inventory and consumables management cost control initiatives and general site financial awareness.

• Represent the function both internally and externally collaborating with internal stakeholders (e.g. Quality other test site managers) and supporting customer interactions as a technical expert in meetings and industry events.

• Coordinate with sister Virus Clearance sites globally ensuring harmonisation of procedures and sharing of knowledge in relation to viral clearance and viral safety

What will convince us

• Masters degree in biology biopharmaceutical biotechnology or relevant disciplines. PhD is preferred.

• Min. 8 years of work experience in biotechnology or pharmaceutical industry paired with managing and leading a team in a GxP environment

• Experience in process development with biological products especially downstream processing

• Experience of hosting audits (MHRAFDA) would be beneficial

• Experience of commercial aspects of facility management would be beneficial

• Experience of maintaining QMS

• Strong leadership skills and the ability to build relationships with internal and external stakeholders

• Strong project management and organisation skills

• Ability to comprehend and draw conclusions from scientific and numerical data

• Strong written and verbal communication 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

• Health & Well-Being: Wide section of health and well-being support such as healthcare plans and health assessment services

Benefits

Attractive Working Conditions

• 35 hours working week

• 29 days annual leave plus 4 public holidays

• 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

Employment Type : Full-Time
Experience: years
Vacancy: 1