Manager of Virus Clearance Services UK

Job Description

Join our Confidence Virus Clearance Services team at Maxim Park.We are looking for a Manager of Virus Clearance Services UK for the Confidence Virus Clearance Team at Sartorius Stedim BioOutsource. In 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 are looking 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 – Your ResponsibilitiesLead 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 safetyWhat will convince usMaster’s 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 environmentExperience in process development with biological products especially downstream processingExperience of hosting audits (MHRA,FDA) would be beneficialExperience of commercial aspects of facility management would be beneficialExperience of maintaining QMSStrong leadership skills and the ability to build relationships with internal and external stakeholdersStrong project management and organisation skillsAbility to comprehend and draw conclusions from scientific and numerical dataStrong written and verbal communication skillsExcellent skills in Microsoft packages such as Word, ExcelIn order to commence working with us, the successful candidate must have the right to work in the UK.What we offerAs 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 offeringsMaking an impact right from the start: Comprehensive onboarding, including a virtual online platform – even before joiningWelcoming Culture: Mutual support, team-spirit and international collaboration; communities on numerous topics such as coaching, agile working and businesswomen networkHealth & Well-Being: Wide section of health and well-being support such as healthcare plans and health assessment servicesBenefitsAttractive Working Conditions35 hours working week29 days annual leave, plus 4 public holidaysFree parking on siteFree hot and cold drinksRegular social eventsHealth & WellbeingCompetitive benefits package, including:Private Medical InsurancePrivate Dental InsuranceGroup Life AssuranceTravel Insurance (Employee Paid)Salary Sacrifice Health Assessment ServiceSalary Sacrifice Cycle to Work SchemePlanning Ahead For Your FutureGroup Personal Pension PlanGroup Income ProtectionSalary Sacrifice Will Writing Service