Make your mark for patients
To strengthen our Clinical Manufacturing Quality department, we are looking for a talented profile to fill the position of: Development Quality Lab Operations Partner – Braine l’Alleud, Belgium
About the role
As a Dev Quality Lab Ops Partner you will be ensuring the establishment, implementation, maintenance, and continuous improvement of an effective Quality Management System (QMS) linked to product development from phase I to commercialization. This position will directly support the Labs ＆ Dev Compliance Quality Lead to ensure proper oversight, from a global quality perspective of Analytical Dev Laboratories.
You will work with
This will be achieved through proactive and structured collaboration with key internal stakeholders across UCB sites in Braine, Slough, and Leuven, ensuring alignment on quality objectives and compliance requirements. In addition, the role will engage closely with external partners, particularly QA functions.
What you will do
The mains task for Quality System are :
- Support all digital projects in CMC Dev a Business QA
- Supplier qualifications, maintain the training material associated to it, ease the supplier qualification exercises for development activities. Ensure all information available in the different databases is up to date.
- Deviation, CAPA and investigation management: liaise with dev key stakeholders all CMC entities (located in Braine, Slough) not limited to ADS, CSC, in order to maintain common practices with regards to deviation management, CAPA and Investigation within development entities
- Change control management: liaise with dev key stakeholders, all CMC entities (located in Braine, Slough, Monheim) not limited to ADS, CSC in order to maintain common practices with regards to change control management within development entities
- Management/annual review for Development entities all CMC entities: coordinate the development management review, ensuring principles mentioned in the associated corporate procedure are fulfilled for development entities
- Internal audits management for Development entities all CMC entities, liaise with dev key stakeholders in order to maintain common practices with regards to internal audit within development entities, coordinate and update the development internal audit schedule, ensuring appropriate application of the audit planning. Act as co auditor for internal Audit.
- Manage monthly Deviation/CAPA/Investigation/Change Control KPIs at Development: define with development stakeholders appropriate KPIs to be used on a monthly basis and during yearly management review exercises
- Issue Copy: monitor KPIs related to their implementation
- Participate in internal audits and self-inspections.
- Provide comprehensive quality support to all relevant business functions.
- Promptly identify issues and escalate them to the relevant management personnel.
- Act as Business QA by offering support for both initial equipment qualification and regular reviews of validation status
- Support as QA No-GMP activities
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
- Minimum of five years’ experience in a Quality Assurance role within the pharmaceutical industry.
- Fluent English communication (oral and written); any additional languages are a plus.
- Knowledge of QA, QMS, and technical aspects of pharmaceutical development required
- QA/Compliance experience in laboratory compliance and Quality Systems is an asset
- Ability to work autonomously for the assigned activities with limited supervision
- A good understanding of current regulatory requirements and Quality Standard (GMP, ICH, USP, WHO) and an ability to interpret current regulations and requirements in the product development and clinical trials context is essential.
- Possessing specialised knowledge of data integrity regulations is considered a valuable qualification.
- Demonstrated experience in conducting root cause analysis
- Strong interpersonal skills, as well as excellent verbal, written, and presentation abilities are a must
- Exhibits strong collaboration and leads projects efficiently, leveraging advanced organizational and analytical skills.
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.