Make your mark for patients
To strengthen our Global Engineering Quality department, part of External & Clinical Supply Quality we are looking for a talented profile to fill the position of: Engineering Quality Lead – Braine l’Alleud, Belgium
About the role
The Engineering Quality Lead is a key role in UCB’s global growth and expansion plans. The role will create a global quality oversight process for the management and execution of investment projects. Additionally, the position will support the creation of a global Engineering Quality Process Landscape.
The position is responsible for ensuring the quality and efficiency of the engineering processes within our organization works closely with cross-functional teams, collaborates on process improvement initiatives, and contributes to overall compliance and sustainability.
Key responsibilities include providing leadership and quality expertise in driving strategic and operational Quality Assurance activities associated with the global team that is responsible for overseeing engineering projects, integrating new technologies for automation and digitalization, emphasizing safety enhancing the workplace experience for employees.
You will work with
Your key stakeholders are the Global Engineering department (Engineering, Sites and Facilities), the Corporate Process Owners of engineering and qualification processes as well as with Global and Local Quality Functions. Additionally, you will work closely with CapEx Project Teams, Manufacturing (commercial and clinical), local Engineering and Qualification & Validation Teams.
What you will do
Global Quality Oversight
1. Ensure global quality oversight for CapEx projectsAsses the current ways of ensuring quality oversight in CapEx projects within UCBAlign quality oversight approaches of CapEx projects where reasonableSupport in onboarding of new QA representativesDevelop a global quality oversight based on the needs of the project teams and especially the QA representativesImplement and maintain global quality oversight that brings added value to CapEx projects
2. Act as global point of contact for project QA representatives
3. Ensure the creation of state-of-the-art corporate standards and procedures in close cooperation with the CPOs
4. Ensure compliance with GxP regulations, guidelines and internal quality practices
5. Collaborate with engineering teams to develop and execute process improvement projects
6. Collaborate with the operational quality functions to ensure the global engineering standards/processes are followed and to harmonize procedures across UCB
7. Act as project QA for global engineering projects and initiatives
8. Provide expert quality advice and support on engineering quality topics
Engineering Strategy
9. Contribute to the development and execution of the Engineering strategy & roadmap
10. Identify and assess regulatory and quality risks related to engineering activities and collaborate on the associated mitigation plans
11. Ensure alignment with the quality objectives
12. Co-drive the change management linked to the Engineering strategy & roadmap
General
13. Deputize the Head of Engineering Quality in times of absence
14. Drive personal training and development activities to meet the needs of the business and professional career development
15. Promote best practices throughout the team
16. Exemplify the core values of the team ‘Care, Empowerment & Positivity’
Interested? For this position you’ll need the following education, experience and skills
17. Requires an engineering or scientific master’s degree or equivalent
18. Significant experience in the pharmaceutical industry, with solid knowledge in Engineering and Quality Assurance
19. Fluent English communication (oral and written) required; French communication skills are a plus
20. Expertise in Engineering Quality processes: maintenance, metrology, commissioning, qualification, equipment, premises and utilities
21. Understanding of CapEx projects management in design and execution phase
22. Familiarity with global regulatory guidelines related to engineering (e.g., EU GMP Guide Annex 15, ISPE Baseline 5, ASTM E2500)
23. Ability to assess risks, propose pragmatic solutions, and manage complexity in a global matrix environment
24. Effective communicator with strong interpersonal skills, able to lead, influence and support cross-functional teams
25. Experience in continuous improvement, harmonization projects, or change management is an asset
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!