Manager of Virus Clearance Services UK

Overview

The Manager will oversee GLP operations in Confidence Virus Clearance Services UK. Responsibilities include ensuring an adequate number of qualified personnel, appropriate facilities, equipment, and materials are available for the timely and proper conduct of regulatory studies. The role covers managing the test facility at Maxim Park, ensuring compliance with GLP, overseeing regulatory work on site, allocating resources to GLP studies, reviewing documentation, managing the quality management system, and supervising the commercial aspects of facility management. The Manager will also attend customer meetings and provide technical support regarding viral safety of biopharmaceutical products.

Responsibilities

• Lead and manage GLP-compliant operations, ensuring adequate staffing, facilities, equipment, and materials.
• Provide line management and leadership to a team of approximately six direct reports, ensuring capability, training, and accurate records of qualifications and experience.
• Oversee planning and execution of GLP studies, including resource allocation, coordination with Study Directors and Principal Investigators, and approval of study plans, amendments, and master schedules.
• Maintain full regulatory compliance with GLP standards and relevant guidelines (ICH Q5A, GLP SI 3106, OECD).
• Own and maintain quality systems and assurance programmes, including SOP approval, deviations, change controls, audits, and ensuring Quality Assurance activities align with GLP principles.
• Act as site lead for inspections and audits, hosting regulatory (MHRA, FDA) and customer inspections, and serving as the named individual on the operator licence where required.
• Ensure operational and commercial oversight of the facility: supplier and test site approval, inventory and consumables management, cost control initiatives, and general site financial awareness.
• Represent the function internally and externally, collaborating with Quality and other test site managers and supporting customer interactions as a technical expert in meetings and industry events.
• Coordinate with sister Virus Clearance sites globally to harmonise procedures and share knowledge on viral clearance and viral safety.

Qualifications

• Master's degree in biology, biopharmaceuticals, biotechnology or related disciplines; PhD preferred.
• Minimum of eight years of experience in the biotechnology or pharmaceutical industry, including managing and leading a team in a GxP environment.
• Experience in process development with biological products, especially downstream processing.
• Experience hosting audits (MHRA, FDA) is beneficial.
• Experience with the commercial aspects of facility management is beneficial.
• Strong leadership skills and ability to build relationships with internal and external stakeholders.
• Strong project management and organisational skills.
• Ability to interpret and draw conclusions from scientific and numerical data.
• Excellent written and verbal communication skills.
• Proficient with Microsoft Office (Word, Excel).
• Right to work in the United Kingdom.

Benefits

• Personal and Professional Development: mentoring, leadership programmes, internal seminar offerings.
• Health & Well-Being: healthcare plans, health assessment services.
• Working Conditions: 35-hour work week, 29 days annual leave plus four public holidays, free parking on site, free hot and cold drinks, regular social events.
• Competitive benefits package: private medical and dental insurance, group life assurance, travel insurance (employee paid), salary sacrifice options.
• Planning Ahead for Your Future: group personal pension plan, group income protection, salary sacrifice cycle-to-work scheme, will writing service.