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 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. In addition, you will identify and lead initiatives for both the Complaints and Escalation processes which result in continuous improvement and compliance to regulations. Responsibilities also include facilitating routine network meetings, completing annual Quality System Management Reports, updating procedural documentation and training, as well as generating KPI/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
GlobalEscalation Process
Take ownership as GMP Corporate Process Owner (CPO) of the Escalation Management Process:
1. 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.
2. 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.
3. 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.
4. Complete annual assessments of the Escalation Process to determine if improvements are required.
5. Manage deviations, CAPAs, audit/inspection responses, including eQMS system transactions, as necessary.
6. Generate KPI metric data and completes data analytics in support of process performance and improvement.
7. Build strong, collaborative relationships with the network of UCB key stakeholders (called Entity Process Owners or EPO) 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.
8. Collaborate with Global Auditing & Compliance, to align auditor expectations & potential preparation on process specific topics for internal/external audits.
Complaints Management Process
Serve as back-up to the GMP Corporate Complaints Management Process Owner (CPO):
9. 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. Leads process review discussions during Health Authority inspections, as required.
10. Manage deviations, CAPAs and audit/inspection remediation, including eQMS system transactions, as required.
11. Identify and lead efficiency and improvement initiatives.
12. Generate KPI metric data and data analytics in support of process performance and improvement.
Interested? For this position you’ll need the following education, experience and skills
13. Bachelor’s or Master’s degree in a relevant scientific discipline.
14. Fluent English communication (oral and written, at minimum C1 level); any additional languages are a plus.
15. 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.
16. Combination Product and Device QMS and regulatory knowledge/experience is preferred.
17. 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, ...).
18. Requires demonstrated capability to resolve conflict, driving consensus and collaboration to a final decision.
19. Should be able to effectively interact with and influence senior internal and external personnel on many aspects of process and project related matters.
20. Requires the ability to independently analyze data and information to draw conclusions and make effective decisions.
21. Requires the ability to manage projects/ activities across global geographies within the area of expertise.
22. 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!