Complaint Management Quality Lead > UCB > Joboolo BE :
Société : UCB Lieu : Braine-l'Alleud Wallonia Site source : Talent BE
You'll also directly oversee the outsourced Central Complaint Unit, managing day-to-day market complaints for Global products.
Moreover, you'll serve as the eQMS complaint flow super user, providing expertise and serving as the primary point of contact for the Global Product QualityManagement organization post-system go-live.Who you'll work withCollaboration in this role will be key.
You will be working closely with stakeholders from different departments, including Manufacturing sites, Affiliates, UCBCares, Vendor QualityLeads and other relevant teams to drive the compliant performance of the complaintmanagement program.
You'll establish and maintain relationships with Subject Matter Experts (SMEs) and Entity Process Owners (EPOs) to ensure cohesive integration of processes and compliance standards.
Additionally, you'll manage the Central Complaint Unit responsible for Global product market complaintmanagement.
Furthermore, your role extends to being the primary eQMS complaint flow super user, offering expertise and support to the Global Product QualityManagement organization post-system implementation.What you'll doComplaintManagement Process:
Act as the GMP Corporate Process Owner (CPO) for ComplaintManagement, driving global procedural requirements and associated documentation, English version of training linked to the process, as well as tracking and trending of complaint performance and driving improvements with the various teams involved in the process.
Establish communication and collaboration plans with UCB's key stakeholders (Entity Process Owners - EPO) to promote best practices, provide expert guidance, and foster an active feedback culture within the organization.Collaborate with the GMP QMS Lead to plan and manage process-related changes across the organization, ensuring effective change management.Develop and implement a governance model for continuous process improvement and performance monitoring using key indicators.Ensure compliance with regulatory standards through the Regulatory Intelligence Network and industry benchmarking.Maintain readiness for inspections on procedural documents, trainings, and inspection packages owned by the CPO.
Participate within inspections and audits, as required.
Align with Global auditing and compliance for internal/external audits on process-specific topics.Drive the integration of the Complaint process within the eQMS (Veeva Source).Central Complaint Unit Oversight:
Manage the contracted services provided by the Central Complaint Unit team, ensuring compliance with UCB's complaintmanagement program and ensure associated personnel are properly trained.
Monitor service KPIs and Metrics, identifying improvement areas and organizing the Service Provider - UCB Steering Committee.Trending & Tracking:
Generate and provide product complaint performance trending for utilization at the routine Complaint Committees, as well as other forums as required.
Ensure visibility on complaint trending for senior leadership.Monitor process performance and KPI reporting.eQMS responsibilities:
Serve as the primary eQMS super user, providing support, troubleshooting, and solutions for end-users within the Global Product QualityManagement organization.Aid in onboarding new users and keep departments informed about system updates.Actively gather and relay user feedback for system enhancements.Collaborate with the Process Data Owner (PDO) team to refine the Source QMS system.Adhere to UCB HSE and Corporate policies while pursuing personal training and development for professional growth.Interested? For this role we’re looking for the following education, experience and skillsDepending on region, a Master’s degree in a relevant scientific discipline (Pharmaceutical, Bio-Engineering, Microbiological or related science) or equivalent experience required.At least 10 years’ experience in the pharmaceutical/biologics industry in a Quality Assurance role, dealing with Biopharmaceuticals/Advanced Therapies.
ComplaintManagement/investigation experience is strongly preferred.
Operational GMP experience is a distinct advantage.
Demonstrated leadership experience, including experience leading teams preferably of 10-15 people.
Expert knowledge and understanding of applicable regulations, quality principles, relevant business processes and techniques.
Profound expertise within Drug Substance and/or Drug Product manufacturing of pharma/biopharma drugs.Combination Product and Device QMS and regulatory knowledge/experience preferred.Must have a process improvement mindset, able to influence different stakeholders, find common ground and bring stakeholders closer together with aligned approach.Must have the ability to independently generate and analyze data and information to draw conclusions and make effective decisions.
The ability to generate and analyze data within excel is required.
Must have ability to identify risks and propose corrective actions within areas of expertise.
Also demonstrates initiative and the ability to help others solve problems in a creative and practical way.Able to generate enthusiasm and commitment to strategic priorities.Must be able to effectively interact with and influence senior internal and external personnel on many aspects of process and project related matters.Must possess excellent interpersonal, verbal, and written communication skills at all levels internally and externally especially at senior management levels.Be able to coach/train/mentor colleagues and deliver training within area of expertise.Fluent in English, French is an asset.If you are interested to learn more about R&D within UCB, please find more information here .RANDATUCBAre 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! UCB Braine-l'AlleudWallonia
