Operations Manager - Clinical Trial Supplies

Our Client is an independently owned and operated company that works exclusively with Clinical Trial materials. The UK site provides secondary packaging, labelling and distribution of Clinical Trial Supplies for sponsor company organisations. Their facility near Reading serves as the packaging and distribution hub for Clinical Trial materials to Europe and the rest of world.

They are now seeking an Operations Manager to join their dynamic team. This position is a full-time permanent role and will be site based near Reading, Berkshire.

Job Purpose

• This position is responsible for the management of the Operations group at the UK facility. The role has direct supervision of the Packaging and Warehouse colleagues and will be responsible for inductions and ensuring appropriate training of direct reports.
• The primary function of the role is ensuring overall GXP compliance with all procedures affiliated with receiving, storing, packaging, returns processing, and disposition of clinical supplies.
• The role also has responsibility for oversight of the short-term packaging schedule with a view to determining staff requirements for the UK facility. The role is also responsible for facilities management at the UK site and ensuring that required preventative maintenance is conducted as required.

Key Areas of Responsibility

• Collaborates with Head of Operations - UK, Project Managers and Distribution Project Managers in the UK.
• Oversees all GXP activities related to packaging of clinical materials.
• Oversees all activities related to receiving, storing, and returns processing of clinical materials within the warehousing area.
• Assists and ensures that all Operations personnel follow all policies and SOPs in accordance with GXP and as specified.
• Act as primary point of contact for managing Operations related SOPs, Deviations, CAPAs and delegates tasks as required to ensure timely completion.
• Work with Project Management to ensure that kit mock-ups, packaging samples and material specifications are appropriate for use within Operations.
• Works directly with representatives from Operations, Quality Assurance and Project Management in resolving any discrepancies.
• Assures that qualified individuals are GXP trained to perform their respective job relative to handling and / or processing clinical supplies.
• Coordinates with Quality Assurance to maintain GXP and SOP compliance within the Operations group.
• Participate in planning meetings, initial study discussions with client regarding packaging designs and project tracking meetings.
• Evaluate processes and procedures to identify gaps and opportunities for process improvements.
• Maintain operational metrics tracking and present at relevant meetings.
• Participates in client audits and visits as appropriate.
• Coordinates with other departments to meet project timelines.
• Oversees the Operations group to ensure the management of all medicinal products and ancillary materials, and the material flow of these goods as well as the operational activities that support the maintenance of the facility and use of the equipment.
• Develop and maintain packaging room schedules to identify when jobs will be executed and which personnel will be assigned to each room.

Qualifications and Experience

• BSc or equivalent in a scientific subject is desirable but not essential.
• Strong knowledge of the pharmaceutical industry.
• Knowledge of UK and EU GMP and GDP.
• Familiarity with Clinical Trials packaging and supply, an understanding of the concept of placebo controlled randomized Clinical Trials.
• Excellent interpersonal skills.
• Excellent reading and writing skills.
• Excellent communication skills.
• English literacy.
• Excellent mathematical skills.
• Computer literacy skills.
• Attention to detail.

In return our client is offering a basic salary of around £55,000 - £65,000 per annum basic plus benefits for the successful Candidate. (Salary is negotiable dependent on experience. More may be available for an exceptional candidate).

Please send your C.V to Lorraine Roger, Director at Atom Recruitment Ltd.