Quallity Lead System - Braine-l'Alleud, België - UCB S.A.

UCB S.A.

Geverifieerd bedrijf

Braine-l'Alleud, België

1 week geleden

Geplaatst door:

Sophie Dubois

beBee Recruiter

Beschrijving

Make your mark for patients
To strengthen our, we are looking for a high caliber, self-motivated, Quality Lead Systems CPO based in
Braine l'Alleud, Belgium

At UCB everything we do starts with a simple question: "How will this make a difference to the lives of people living with severe diseases?" We do that by connecting our ground-breaking science with patients and their families around the world living with the physical and social burdens of autoimmune and neurological disorders. Those connections offer new perspectives, drive innovation, and offer the hope of a new generation of therapies that will help improve lives on a global scale.

You like to work in an
environment where you will be**:

Take ownership as Global Process Owner(s) of one core and/or several ancillary Quality Systems, starting with GMP/GDP Deviations, Change Controls and Quality Agreements.
Ensure the processes are in compliance with authority regulations, leveraging the Regulatory Intelligence Network in UCB and Industry Benchmarking.
Owns the documentation (UCB policy, standard & procedures) and training in English linked to the Quality System Processes.
Collaborate and cocreate with the GMP/GDP QMS Lead in line with changes linked to the Quality System processes owned by the CPO or crossprocess topics.
Establish and build a network with UCB key stakeholders in relation with the identified Quality System processes.
Coach Quality professionals by providing expert advice and support in relation with the identified processes.
Build, establish and develop a governance model and process which fosters continuous quality process improvement and key indicatorbased performance monitoring of the Quality System.
Perform the Quality System Management Review.
Lead the Global Change Control Committee according to the procedure with crossfunctional DMSO, RA and Quality management.
Maintain where possible a global approach and global process, exceptions should stay exceptions with a clear rationale agreed.
Single Point of contact for the PDO to support update to the IT systems used for the process
Work closely with Quality colleagues, DMSO, RA, Safety & other Business stakeholders globally, site & affiliates, in an effective and efficient way.
Upon request deputize for the Head of Quality Operations Solutions in the context of the eQMS project
Promote Best Practices throughout UCB in relation with the identified processes.
Maintain a communication plan on changes, improvements and Best Practices
Drive an active feedback culture within the organization on the identified processes.
Ensure Change management across the organization, for any changes implemented on system or processes, in relation with the identified processes.
Ensure a constant Inspections Readiness.
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**:

Minimum of 5 years working in the pharmaceutical/biologics industry in a process improvement position. Operational GMP experience would be an advantage.
Certification on Project management, Change Management or Process improvements is an asset.

Why you should apply
We can offer you freedom to take space to pursue your own ideas and make a difference. Opportunity to gain internal and external visibility through interactions with other UCB teams and with world-renown academic investigators.

Opportunity to grow both as a drug hunter and leader through participation in project teams and our career/personal development programs.

At UCB, we strive to attract passionate and outstanding talents who thrive on change and are ready to bring real value to patients.

Working for us you'll discover a place where you can grow and express your full potential. We place an emphasis on innovation, collaboration and impact.

Through meaningful recognition and a motivating work atmosphere, we aim to provide an optimal experience by caring about and valuing our employees - just as we do for the patients we serve.

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 around 8,500 people in all four corners of the globe, inspired by patients and driven by science.

Why work for 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 equitable 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 emp