Quality Compliance Officer

Clinigen

. Ensure compliance functions are carried out in line with domestic license obligations .

Posted 10/7/2026full-timeWeybridge • United KingdomMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Quality Compliance processes, including the management of training materials and compliance reporting. Proficient in maintaining Document Management Systems and ensuring adherence to GxP training standards.

Highest-signal resume keywords

MHRA Import Notification ProcessingHPRA Exempt Medicinal Product NotificationsQuality Compliance ERP Component MaintenanceDocument Management System (eQMS) ManagementGxP Training Compliance Oversight

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality ComplianceDocument ProcessingTraining Matrix MaintenanceSOP CreationPolicy Training Course DevelopmentCompliance ReportingClinical Needs Letter ProcessingIn-House Authorisation ProcessingDocument ObsoletingDocument Archiving

Soft Skills

CollaborationTrainingCommunication

Tools & Technologies

EQMSLMSERP Systems

Industry Keywords

GxPQuality Management SystemCompliance FunctionsClinical NeedsTraining Compliance

Tech Stack

Tools & technologies

ERP

About the role

Key responsibilities & impact

Ensure compliance functions are carried out in line with domestic license obligations
Assist in the Quality Management System for Document and Learning Management in line with relevant procedures
Process MHRA import notifications, acknowledgements, objections and further information requests
Process HPRA exempt medicinal product notifications
Provide cover for daily Quality Compliance duties in cooperation with colleagues
Create and maintain Quality Compliance ERP components
Process special clinical needs letters and in-house authorisations
Support document updates, obsoleting and archiving requests in the eQMS
Maintain Document Processing and Document Management work instructions
Maintain training matrices, employee records, roles and reporting structures in the LMS
Create and maintain SOP and policy training courses and ensure training materials remain current
Report training-record compliance status and identify gaps and overdue training
Act as Clinigen LMS administrator and train local LMS administrators across global sites
Oversee GxP training compliance and the annual review and update of training materials

Requirements

What you’ll need

Processing of MHRA import notifications and subsequent acknowledgements, inc. objections and further information requests
Processing HPRA exempt medicinal product notifications
Ensure cover for all operational daily Quality Compliance duties in co-operation with colleagues
Creation and maintenance of Quality Compliance ERP components
Internal and External processing of special clinical needs letters and in-house authorisations
Respond and support the business requests for document updates, document obsoleting and document archiving in eQMS
Maintain the Document Processing and Document Management associated work instructions
Keep training matrices relevant and up to date
Ensure employee names, roles and reporting structure is current within the LMS
Respond and support the business requests for the creation of all courses for the SOPs & Policies from the eQMS and other Clinigen training courses
Ensure training material is correct and current
Provide reports of compliance status of training records
Act as an LMS admin for Clinigen and provide training to local LMS admins across the Global Clinigen sites
Maintain oversight of GxP training compliance and annual review and update of training material
Create and maintain the process on how to report monthly training for GXP training compliance status to identify gaps and overdue training

Benefits

Comp & perks

27 days holiday plus 8 bank holidays
Pension contributions 4.5% matched
Life assurance 4 x annual salary
Flexible Benefits Platform with £25/month Company contribution
Annual salary review
Independent financial advice service
Enhanced Employee Assistance Programme
Shopping discounts with retailers
Long service awards
Recognition scheme & employee of the year awards