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Complaint and Escalation Management Quality Lead
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Make your mark for patientsTo strengthen our Global QA department , we are looking for a talented profile to fill the position of: Complaint and Escalation Management Quality Lead – Braine l’Alleud, BelgiumAbout the roleAs part of the Global Quality Organization, reporting to the Head of Complaint and Escalation Management, you will be the Corporate Process Owner for the company-wide Escalation program which utilizes cross-functional assessment of significant quality and compliance issues to determine the appropriate resolution (up to whether or not recall of product is required) and drive continuous improvement initiatives to enhance the Complaints Management program. You will ensure alignment, continuous improvement, efficiency and compliance with regulations for both the Escalation Management and Complaints programs. Responsibilities include leading cross-functional assessment of significant quality issues to determine appropriate actions, facilitating routine network meetings, completing annual Quality System Management Reports, updating procedural documentation and training, managing improvement projects, and generating KPI/data analytics.You will work withIn this role, you will collaborate with worldwide UCB stakeholders, including Senior Management. You will routinely interact and drive consensus with cross-functional groups including such roles as Quality, Technical, Regulatory, Safety, Supply Chain and many others. These interactions will occur for operational decisions, as well as project-related activities. You will work with cross-functional teams on improvement projects and data analytics to ensure compliance and efficiency.What you will doGlobal Escalation Management Process• Take ownership as GMP Corporate Process Owner (CPO) of the Escalation Management Process.• Owns the Global documentation (UCB policy, standards & procedures) and training (in English) linked to the process and associated processes .• Identifies and leads efficiency and improvement initiatives• Generates KPI metric data and completes data analytics in support of process performance and improvement• Lead cross-functional assessments of significant quality issues to determine appropriate resolution (e.g. if recall of product is required).• Build strong, collaborative relationships with the network of UCB key stakeholders (called Entity Process Owners or EPO) in relation with the identified process to:o Ensure robust and timely communication occurs regarding changes and improvementso Promote Best Practices throughout UCBo Coach Entity Process Owners by providing expert advice and supporto Drive an active feedback culture within the organizationo 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.• Perform the Quality System Monitoring Report used in the Management Review Process.• Ensure the process is in compliance with Health Authority regulations, leveraging the Regulatory Intelligence Network in UCB 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 and audit/inspection preparation/participation/observation remediation (including eQMS system transactions).Global 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 preparation/participation/observation remediation (including eQMS system transactions).• Identifies and leads efficiency and improvement initiatives.• Generates KPI metric data and completes data analytics in support of process performance and improvement.Interested? For this position you’ll need the following education, experience and skills• Bachelor’s, master’s degree or an education in a relevant scientific discipline• Fluent English communication (oral and written); any additional languages are a plus.• Minimum of 10 years working in the pharmaceutical/biologics industry in a Quality Assurance role, dealing with Biopharmaceuticals/Advanced Therapies• Excellent oral and written communication skills• Operational GMP experience, including extensive experience leading GMP investigations (e.g. root cause analysis, CAPA identification, etc.) and demonstrated knowledge of application of regulations to compliance scenarios is required• Combination Product and Device QMS and regulatory knowledge/experience is preferred• In-depth knowledge of regulatory requirements and Health Authority compliance expectations for reporting of quality-related issues (e.g. GMP, Clinical, etc.).• Requires demonstrated capability to resolve conflict, driving consensus and collaboration to a final decision.• Should be able to effectively interact with and influence senior internal and external personnel on many aspects of process and project related matters• Requires the ability to independently analyze data and information to draw conclusions and make effective decisions.• Requires the ability to manage projects/ activities across global geographies within the area of expertise• Should posses excellent interpersonal, verbal, and written communication skills at all levels internally and externally, including Senior Management levels• Should possess excellent interpersonal, verbal, and written communication skills at all levels internally and externally especially at senior management levels .Are you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you
