Global Analytical Compliance & Risk Leader

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

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