Quality Head Large Molecules and Injectables (d/f/m)

Quality Head Large Molecules and Injectables (d/f/m), Global Quality STO, Kundl, Austria

Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.

Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally.

The incumbent will be responsible to lead as disciplinary manager the inhouse and external Quality Large Molecules (LM) and Quality Biosimilar network and will provide guidance to all Site Quality Heads of the global platform in critical quality decisions and will ensure Quality unit independency in decision making on batch disposition.

This role can alternatively be filled in Germany, Switzerland or Slovenia

Join us as a Founder of our 'new' Sandoz!

Your key responsibilities:

Your responsibilities include, but are not limited to:

• Act as Quality Business Partner to Operations Head of Large Molecules and Injectables for large strategic projects and routine work.
• Manage, support and supervise the Site Quality Heads and their Quality Units in the assigned sites, ensuring implementation and continuous improvement of Quality systems and programs, adequate resource planning, performance management and quality unit independency.
• Ensure effective quality oversight over external manufacturer of the platform, provide governance, steering and ensure adequate escalations and remediation processes in place.
• Ensure timely quality reviews during due diligences of new business opportunities, indicating risks and potential showstoppers, as applicable and definition of potential remediation actions.
• Ensures an active inspection readiness program is in place driving continuous inspection readiness.
• Design and implement together with Head of Quality Development an early-involvement-by-operations approach for pipeline products at biosimilar development organizations
• Together with Global Quality Compliance monitor regulatory and industry trends specifically in the space of biosimilars, implications for the platform and determine opportunities for continuous improvement of the Sandoz Quality Management System
• Drive and foster people development and talent management initiatives across the sites, ensuring proper development for Quality associates in the assigned sites and adequate implementation of Organization and Talent review.