Analytical Compliance and Risk Program Lead

UCB; Bulle; Hybrid; CHF 110.977 - 166.465; Vollzeit

Zusammenfassung

UCB is seeking an Analytical Compliance and Risk Program Lead who is strategic, collaborative, and quality-minded to join the Analytical Industrialization Program at our UCB campus in Belgium. You will lead a global analytical compliance and risk program across the product lifecycle, shaping governance, enabling risk-based decisions, and ensuring access to the right standards, processes, and training.

This role partners with analytical, regulatory, quality, and lifecycle teams, represents UCB

Qualifikationen

• Bachelor’s, Master’s, or Ph.D. in a relevant scientific discipline.
• 10+ years of pharmaceutical/biotech industry experience.
• Strong experience in analytical CMC and regulatory guideline implementation.
• Understanding of analytical control strategies (methods, specifications, stability, impurities).
• Experience with risk management and global regulatory compliance.
• Supported audits, inspections, or responses to FDA, EMA, PMDA, or other health authorities.

Aufgaben

• Chair the analytical compliance & risk core team and drive global alignment on priorities, decisions, and risk posture.
• Maintain analytical 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.

Kenntnisse

Analytical CMC

Regulatory guidelines

Risk management

Audits & inspections

Ausbildung

Bachelor’s, Master’s, or Ph.D. in a relevant scientific discipline

Jobbeschreibung

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-l’Alleud, 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 training. In 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 Bachelor’s, Master’s, 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 Bachelor’s, Master’s, 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 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 [e-mail]. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.