Quality Partner Benelux

il y a 1 mois

Brussel, Belgique UCB S.A. Temps plein

Make your mark for patients

To strengthen our Market Quality Europe department, we are looking for a talented profile to fill the position of: Quality Partner Benelux – Brussels, Belgium

About the role

As a Quality Partner Benelux, you will collaborate with the responsible Quality Lead to ensure that global quality practices are integrated within the Benelux area, thereby meeting compliance obligations in line with UCB and local regulations. This role involves maintaining the GDP status of the Belgian and the Dutch affiliates in accordance with both current national and EU GDP and legal requirements, managing the local Quality Management System, and identifying and mitigating issues and risks. Additionally, it highlights improvement opportunities and facilitates the development of solutions. Ensuring all Market Quality deliverables are achieved in a timely manner is a key responsibility. The role involves acting as the delegate of Responsible Person (RP) for UCB Pharma S.A. in the Belgian affiliate, following GDP regulations, local laws, and UCB procedures. There is also an option to be nominated as the RP (and/or QP) for UCB Pharma B.V. in the Netherlands under the same guidelines (+GMP to a limited scope).

You will work with

In this role, you will collaborate closely with the responsible Quality Lead and the local quality team to integrate global quality practices within the Benelux area. You will work together to maintain the GDP status of the affiliates, manage the local Quality Management System, and address issues and risks. The daily interactions are with both internal stakeholders e.g. in market supply, safety, medical, business and UCB global quality, as well as external customers and vendors.

What you will do

- Maintain an effective and compliant local Quality Management System (QMS), which is part of the UCB global QMS
- Ensure the execution of the local QMS: e.g. management of complaints, deviations, change controls and CAPAs according to UCB SOPs, in a timely manner, by using the relevant UCB electronic systems. As well as:
- Ensure quality oversight to local GxP vendors

- Support establishment of self-inspection/internal and external audit plans, host GDP/GMP audits in the affiliates

- Support periodic Management Review, and ensure escalation of (potential) issues

- Support periodic Product Quality Reviews in accordance with the affiliate Marketing Authorisation holder responsibility

- Ensure execution of local recalls, contact to national competent authorities, where needed.

- Ensure compliance to GDP and ensure proper shipping conditions are implemented for secondary distribution, as applicable
- Ensure readiness for all GDP/GMP internal, external and regulatory inspections
- Maintain the local Site Master File and Quality Manual
- Ensure efficient information flow including but not limited to issue escalation and communication of new regulations via the Regulatory Intelligence Network (RIN)
- Ensure any additional requirements imposed on controlled or un-licensed medicinal products by national law are adhered to
- Represent the area in market Quality meetings, market/global Quality projects and improvement initiatives, as requested
- Maintain competence in GDP, and GMP as applicable, through regular training.

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

- Preferred Master's level in a relevant field
- Preferred at least 3 years of experience in the pharmaceutical sector
- Fluent and confident use of at least one local language and English language verbally and in reading & writing
- Knowledge of relevant local legal requirements of the pharmaceutical industry, including the interpretation and practical application of regulations
- Knowledge of EU GDP (+GMP) requirements
- Good quality auditing mindset, root cause and risk management/assessment skills
- Ability to interact and communicate (verbally and written) with internal and external stakeholders on projects, product and quality related matters
- Ability to work with several projects simultaneously, good organizational skills
- Self-motivated team player, able to generate commitment and act as a role model for others
- Readiness to operate across cultures and in a multi-cultural environment
- Analyze data and information to draw conclusions and make effective decisions
- Identify risks and propose corrective actions within areas of expertise. Also demonstrates initiative and the ability to help others solve problems in a compliant and practical way
- Work effectively with remote supervision.

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 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 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 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.

As an Equal Opportunity Employer, we are open to all talent, and adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

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