Overview

The role of Operations Compliance Officer actively supports the Good Manufacturing Practice (GMP) operations at the CGT Catapult Stevenage Manufacturing Innovation Centre. Reporting to the Operations Lead, it’s a hands-on position focused on delivering and continuously improving day-to-day operational processes within the facility. The role ensures full compliance with relevant regulatory standards (MHRA) through development, training and execution of internal policies and procedures while maintaining and building efficiency. In doing so, this role provides critical support to internal stakeholders and our collaborators delivering innovative cell and gene therapies manufactured at Stevenage MIC.Responsibilities

Key FacilitatorsAct as the primary point of contact between CGT Catapult and SMIC CollaboratorsSchedule activities in shared areas and Grade C/B cleanroom “modules” to co-ordinate materials equipment, waste, samples, cleaning and Environmental Monitoring with minimal disruption to manufacturingCollaborate with Quality Control, Quality Assurance, Engineering, Warehouse, Validation suppliers and service providers to support GMP-compliant operationsFacility ManagementOversee facility operations to ensure compliance with procedures and policies.Equipment Owner for operational equipment, ensuring this remains compliant and fit for purposeMonitor contract cleaning services to maintain GMP areas standards and scheduleLead the spills management process and serve as an active member of the spills team.Assist the Warehouse team in managing inventory to ensure continuous supplyManage waste processes, including Human Tissue Waste and Large Volume Liquid Waste, ensuring compliant handling and disposalEnsure the operations team enables a safe working environment across SMIC, taking ownership of relevant risk assessments including COSHH and microbiological containmentEnsure ComplianceOwn and maintain operational policies and procedures within the QMS.Ensure accurate, GMP-compliant completion of facility logbooksManage Quality Records (i.e. Non-Conformance, Change Control, CAPA, OOS/LIR) to closureParticipate in self-inspections and internal audits of operations owned areas and processesSupport the Operations Lead in preparing for and hosting external auditsEscalate quality and health and safety risks to management promptlyDrive Continuous ImprovementConduct root cause investigations, GEMBA walks and process reviews to identify improvementsMaintain Operational KPIs to measure departmental performance and drive improvementDesign and deliver training on operational procedures to ensure consistent understanding and executionThe role may also include other duties as required, in line with its scopeExperience

Experience working in regulated environments, ideally GMP within cell and gene therapy or biopharmaHands-on experience of manufacturing operations, including but not limited to; scheduling, cleaning, supply chain, material transfer, microbiological containment, gowning and waste managementDemonstrated experience contributing to quality records including Deviations, CAPAs and Change Controls within a regulated frameworkDemonstrated skills in building strong cross-functional relationships and providing problem solving support to internal and external stakeholdersSkills, Knowledge and Expertise

Understanding of GMP principles, cleanroom operations and regulatory compliance in a manufacturing environment (essential)Desire to contribute to the cell and gene sector with the personal drive to help advance CGT Catapult’s mission (essential)Ability to manage multiple priorities, adapt to changing requirements and maintain high standards in a fast-paced, patient focused environment (essential)Strong interpersonal, written and verbal communication skills utilised to build trust and collaborate across teams (essential)Self-motivated and solution focused, confident to autonomously manage workload, take ownership and make sound decisions in complex situations (essential)Flexible and open to varied assignments, with a positive attitude towards learning, professional development, and staying up to date with industry’s best practice (essential)Committed to excellent customer service and operational support, delivered in a cost-effective and efficient manner (essential)Proficient in IT applications (Outlook, Work, Excel, PowerPoint) (essential)Willingness to travel as required (essential)Capable of owning and managing quality records and processes within eQMS to support compliant quality culture, including supporting auditsWorking knowledge of Lean Manufacturing methodologies, with the ability to identify and implement process improvementFamiliarity with eQMS and EMS systemsEducation / Qualifications

Bachelor’s degree in Life Sciences or equivalentCGT Catapult is committed to providing an equal, diverse, and inclusive work environment where everyone’s contributions are valued. We celebrate differences, empower, and inspire everyone, because when everyone is included, everyone wins. In 2024, we received bronze accreditation from Inclusive Employers.

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