Job Description

Make your mark for patients

To 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, Belgium

About the role

As part of the Global Quality Organization, reporting to the Head of Complaint and Escalation Management, you will have oversight responsibilities for our complaints management Service Provider, as well as identifying and leading continuous improvement initiatives for both the Complaints and Escalation processes.

You will lead the global Escalation Process that brings together key subject matter experts and senior leadership to determine appropriate resolution of significant quality or compliance issues impacting the company. With deep knowledge of GMP processes and investigation resolution as well as strong leadership skills, you will drive discussions and decision-making that determines the actions required to resolve issues, such as whether or not reporting of an issue to a Health Authority is required and if recall of batches is appropriate. You will ensure the associated processes are robust and aligned with Health Authority requirements.

Responsibilities also include facilitating routine network meetings, completing annual Quality System Management Reports, updating procedural documentation and training, as well as generating KPI metrics/data analytics.

You will work with

In this role, you will collaborate with various stakeholders and senior management within the Global Quality Organization and other departments such as Regulatory, Supply Chain, Technical, Analytical, Safety, Medical, Pharmacovigilance, site Quality and local Quality (i.e. at country level). Additionally, you will work with cross-functional teams on improvement projects and data analytics to ensure compliance and efficiency.

What you will do

Complaints Management Process

• Oversee the performance and management of our contracted Service Provider.
• Identify and lead efficiency and improvement initiatives.
• Manage deviations, CAPAs and audit/inspection remediation, including eQMS system transactions, as required.
• Serve as subject matter expert for the Global Complaint process, providing guidance as needed, as well as update of procedural documentation and associated training. Ensure constant inspection readiness on procedural documents, trainings and inspection packages associated with the Global Complaint process. Lead process review discussions during Health Authority inspections, as required.
• Generate KPI metric data and data analytics in support of performance improvement.

Global Escalation Process

Serve as the GMP Corporate Process Owner (CPO) of the Escalation Management Process

• When notified about a significant quality or compliance issue, you will assess the need for escalation, work with key personnel to define preparation work and timing for escalation and determine if immediate senior management communication and evaluation are required. This requires being able to independently ascertain if recall of material may be warranted.
• With strong leadership skills and robust knowledge of GMP requirements, effectively facilitate (in English) and lead committees to proper resolution of GMP quality and compliance issues. Serve as a mentor to investigation teams, as required.
• Own the Global documentation (UCB policy, standards & procedures) and training (in English) linked to the process. Ensure compliance with Health Authority regulations and constant inspection readiness, leveraging the Regulatory Intelligence Network in UCB and industry benchmarking. Lead process review discussions during Health Authority inspections, as required.
• Complete annual assessments of the Escalation Process to determine if improvements are required.
• Manage deviations, CAPAs, audit/inspection responses, including eQMS system transactions, as necessary.
• Generate KPI metric data and completes data analytics in support of process performance and improvement.
• Build strong, collaborative relationships with the network of UCB key stakeholders in relation with the identified process to discuss improvement plans, promote Best Practices, provide expert advice and support, and drive an active feedback culture within the organization.
• Collaborate with Global Auditing & Compliance, to align auditor expectations & potential preparation on process specific topics for internal/external audits.

Interested? For this position you’ll need the following education, experience and skills

• Bachelor or Master’s degree in a relevant scientific discipline.
• Fluent English communication (oral and written, at minimum C1 level); 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. Robust 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, as well as regulatory knowledge/experience is preferred.
• In-depth knowledge of regulatory requirements and Health Authority compliance expectations for reporting of quality-related issues (e.g. Field Alert Report, Biologic Product Defect report, ...).
• Requires demonstrated capability to resolve conflict, drive consensus to a final decision.
• Ability to effectively interact with and influence senior internal and external personnel on many aspects of process and project related matters is preferred.
• 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 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!

About us

UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are over 9.000 people in all four corners of the globe, inspired by patients and driven by science.

Why work with us?

At UCB, we don’t just complete tasks, we create value. We aren’t afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equal opportunities to do their best work. We ‘go beyond’ to create value for our patients, and always with a human focus, whether that’s on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.

At UCB, we’ve embraced a hybrid-first approach to work, bringing teams together in local hubs to foster collaborative curiosity. Unless expressly stated in the description or precluded by the nature of the position, roles are hybrid with 40% of your time spent in the office.

UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable laws.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on EMEA-Reasonable_Accommodation@ucb.com. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.