Auditor and Risk Manager
il y a 2 semaines
Main responsibilities / Major Activities
Audit conducted by EORTC (internal, towards third parties)
Manages all audits conducted by EORTC.
Generates and maintains the annual audit schedule, evaluating workload and priorities.
Reviews the contracts, agreements and Tasks and Responsibilities lists to ensure EORTC may audit third parties when applicable.
Leads or participates in audits conducted by or on behalf of EORTC (including preparation, conduct, reporting and follow-up of any corrective and preventive actions).
Escalates, as appropriate, where resolution of audit findings is inadequate or where process improvement might be advised.Evaluation and internal control of risks
Works in close collaboration with the Audit and Financial Committee (AFC) of the EORTC Board, as part of the third line of defence towards risk.
Supports with the AFC all communication activities to the EORTC Boards of Directors related to risk management.
Inspections and audits by sponsors
Supports the Processes & Learning department as needed to prepare, conduct, and report on audits by external parties.
Supports the implementation of external audit findings.
Procedures
Oversees the development and maintenance of procedures documentation related to audits conducted by EORTC.
Reviews procedures documentation related to any EORTC audit-related activities.
Reviews procedures documentation that could contain control mechanisms towards all identified risks.
Ensures staff members are adequately trained and adhere to applicable procedure documentation.
Supports through internal audits a consistent way of working across the EORTC.
Acts as a reference in ICH GCP compliance, and other relevant documentation and requirements.
Non-compliance and CAPA management
Reviews the reports and verifies the metrics on reported non-compliances and CAPAs.
Verifies proper reporting of non-compliance to Sponsors and competent authorities.
Advises on the implementation of effectiveness checks on CAPAs.
Profile
University degree or equivalent in Health Sciences or relevant field.
Knowledge of the approach of risk management and control.
5+ years of relevant clinical research experience which includes at least 2+ years of GCP auditing experience.
Experience with clinical CAPAs.
Excellent presentation and communication skills.
Excellent organization and planning skills and details oriented.
Ability to work independently and within a team.
Ability to travel for some time across European countries.
Fluent in English (oral and written), any other European language is an asset.
Benefits:
Permanent contract
Competitive salary package
Hybrid working environment (from Belgium)
30 days holidays (full time)
Meal vouchers
Pension plan
Hospitalisation insurance and ambulatory care
Homeworking allowance
Reimbursement of public transport
Free parking
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