Holzkirchen, Bavaria, Germany
Enriched leadership of 30+ years in Pharmaceutical Quality function with increasing roles, in and outside Novartis/Sandoz. Strong background of GxP areas including QMS, Audit & Compliance & Regulatory requirements of Finished Dosage Forms & API manufacturing. In my current role, I am leading highly motivated team of quality professionals spread across the globe who are working closely with our Injectables CMOs. - Expertise in Sterile / Aseptic Manufacturing & Quality aspects. - Significant track record of Health Authority Inspection Management (US FDA/EU). - Experience of implementation of sustainable Quality Systems, Data Integrity & Culture Change initiatives and projects (new, remediation and divestments). - Ability to deliver strong results in a matrix structure and diverse cultures. - Strongly believe in empowering people to unleash their potential.
Provided leadership and managed Quality related aspects of the operational business of Anti-Infectives & Sterile products manufacturing sites of Sandoz TechOps. Oversight & support to sites to ensure continuous improvements and operational excellence. Sites operations includes API, Sterile API, OSD and Sterile formulation manufacturing spread across Europe and Canada.