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Analytical Compliance and Risk Program LeadUCB • La Gruyère, Fribourg, Switzerland
Analytical Compliance and Risk Program Lead

Analytical Compliance and Risk Program Lead

UCB • La Gruyère, Fribourg, Switzerland
Vor 21 Tagen
Stellenbeschreibung

Make your mark for patients

We are looking for an Analytical Compliance and Risk Program Lead who is strategic collaborative and quality-minded to join our team Analytical Industrialization Program / Industrialization & Network Planning based at our UCB campus located in Braine-lAlleud Walloon Region Belgium.

About the role
You will lead a global analytical compliance and risk program that helps UCB anticipate regulatory expectations and strengthen analytical control strategies across the product lifecycle. You are going to shape governance support consistent risk-based approaches and ensure stakeholders have access to the right standards processes and this role you will help protect compliance across methods specifications stability impurities and analytical regulatory topics for commercial products and future lifecycle management activities.

Who you will work with

You will partner with cross-functional leaders across analytical regulatory quality industrialization and lifecycle management activities to align expectations and accelerate decision-making. You will collaborate with subject matter experts Corporate Process Owners regulatory intelligence networks and external industry groups to translate evolving expectations into practical standards. You will also represent UCB in expert forums and act as a trusted point of contact during audits inspections and regulatory discussions linked to analytical compliance.

What you will do

Chair the Analytical Compliance & Risk core team and drive global alignment on priorities decisions and risk posture.
Maintain analytical compliance governance across methods specifications stability impurities and related regulatory topics.
Anticipate emerging risks through regulatory intelligence benchmarking and input from subject matter experts.
Secure compliant consistent responses to pharmacopeial changes monographs audits inspections and authority questions.
Coach stakeholders and Corporate Process Owners on analytical compliance expectations standards and decision frameworks.
Represent UCB in external expert groups and influence industry approaches to analytical compliance.

Interested

For this role we are looking for the following education experience and skills:

You hold a Bachelors Masters or Ph.D. in a relevant scientific discipline.
You bring at least 10 years of experience in the pharmaceutical or biotech industry.
You have strong experience in analytical CMC and regulatory guideline implementation.
You understand analytical control strategies including methods specifications stability impurities and specification setting.
You have experience with risk management and compliance in a global regulatory environment.
You have supported audits inspections or responses to FDA EMA PMDA or other health authorities.

What you will bring

This is an opportunity to shape enterprise standards influence external thinking and provide visible leadership in a role with direct impact on analytical compliance product quality and regulatory confidence. For this role we are looking for the following education experience and skills:

You hold a Bachelors Masters or Ph.D. in a relevant scientific discipline.
You bring at least 10 years of experience in the pharmaceutical or biotech industry.
You have strong experience in analytical CMC and regulatory guideline implementation.
You understand analytical control strategies including methods specifications stability impurities and specification setting.
You have experience with risk management and compliance in a global regulatory environment.
You have supported audits inspections or responses to FDA EMA PMDA or other health authorities.

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 dont just complete tasks we create value. We arent 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 thats 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 weve 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 Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.


Required Experience:

Senior IC


Employment Type : Full Time
Experience: years
Vacancy: 1
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Analytical Compliance and Risk Program Lead • La Gruyère, Fribourg, Switzerland

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