Complaint and Escalation Management Quality Lead
Contracting – Brabant Wallon
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.
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.
Perform the Quality System Monitoring Report used in the Management Review Process.
Ensure constant inspection readiness on procedural documents, trainings and inspection packages owned by the CPO (accuracy, completeness, etc).
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.
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.
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.
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills.