Complaint and Escalation Management Quality Lead H/F/X

Beschrijving van de functie

Contracting - Brabant Wallon
Corporate Escalation Process: Take ownership as GMP Corporate Process Owner (CPO) of the Escalation Management Process. Owns the Global documentation and training in English linked to the process and associated processes. Build strong, collaborative relationships with the network of the company key stakeholders in relation with the identified process to: Maintain and establish communication plans on changes and improvements Promote Best Practices throughout the company Coach Entity Process Owners by providing expert advice and support Drive an active feedback culture within the organization Collaborate with EPOs in an effective and efficient way to create/improve the process Collaborate with the GMP QMS Lead to plan and manage changes linked to the process. Ensure change management across the organization, for any changes implemented on systems or process. Maintain and further develop a governance model and process which fosters continuous process improvement and key indicator-based performance monitoring of the process. Perform the Quality System Monitoring Report used in the Management Review Process. Ensure the process is in compliance with authority regulations, leveraging the Regulatory Intelligence Network in the company and industry benchmarking. Ensure constant inspection readiness on procedural documents, trainings and inspection packages owned by the CPO (accuracy, completeness, etc). Collaborate with global auditing & compliance, to align auditor expectations & potential preparation on process specific topics for internal/external audits. Manage deviations, CAPAs, audit responses, including eQMS system transactions. Complaints Management Process: Serve as back-up to the GMP Corporate Complaints Management Process Owner (CPO). Serve as subject matter expert for the Corporate Complaint process, updating procedural documentation and associated training. Manage deviations, CAPAs and audit/inspection remediation, as required. Identifies and leads efficiency and improvement initiatives. Generates KPI metric data and completes data analytics in support of process performance and improvement. Work in accordance with HSE and Corporate policy requirements and drive personal training and development activities to meet the needs of business and professional career development.

Jouw profiel

Master's degree in a science-related field. Expert knowledge of applicable regulations, quality principles, business processes, and techniques. Minimum 10 years in pharmaceutical/biologics industry in Quality Assurance, including Biopharmaceuticals/Advanced Therapies. Strong operational GMP experience, including leading investigations (root cause analysis, CAPA) and applying regulations to compliance scenarios. Expertise in Drug Substance and/or Drug Product manufacturing, packaging, and labelling. Knowledge of Combination Product and Device QMS and regulatory requirements preferred. In-depth understanding of Health Authority compliance expectations for reporting quality-related issues (GMP, Clinical). Ability to lead investigations, identify root causes, and define CAPAs. Proficient in Excel, data analytics, and eQMS tools for deviations, CAPAs, audits, and KPI reporting. Fluent in English and French.

Taalvaardigheden

• Frans (troef)

  • Begrijpen : Vaardig - (C1)
  • Schrijven : Vaardig - (C1)
  • Lezen : Vaardig - (C1)
  • Spreken : Vaardig - (C1)

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