Andreas Mayer

Head of Quality Support & Enabling - Drug Substance Manufacturing @Roche

Munich, DE
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Mar 2022 — Present

Head of Quality Support & Enabling - Drug Substance Manufacturing @Roche

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Leading a team of 30 professionalsKey responsibilities- leading the team in a dual leadership model- member of the quality leadership team (QLT) and QA leadership team (QA-LT)- ensuring the compliant and quality manufacturing of drug substances- managing the following quality processes for drug substance manufacturing: qualification & validation processes, environmental monitoring, warehousing, QC, direct material processes, IT systems, etc- partnering with senior stakeholder and leadership teams on local and global levelKey achievements- stabilizing and optimizing the quality team and its processes after reorganization- successful completion of several health authority inspections by FDA, EMA, etc. with no critical observations- enabling the organization to ensure the right level of quality & compliance- guiding the team into self-organization

EDUCATION

2012 — 2014

University of Bayreuth

Master of Science (M.Sc.), Biochemie und Molekularbiologie

2009 — 2012

University of Bayreuth

Bachelor of Science (B.Sc.), Biologie

ABOUT ANDREAS MAYER

Head of Quality Support and Enabling at Roche

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Andreas Mayer — Head of Quality Support & Enabling - Drug Substance Manufacturing at Roche in Munich, DE | Unifers