Experience

Pieris Pharmaceuticals

• United States
• Biotechnology Research
• 1 - 100 Employee

• Head Quality Assurance

  • Feb 2020 - Present



Novartis

• Switzerland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Product Quality Lead

  • Jan 2017 - Feb 2020

  End-to-end product quality stewardship of biologics across the global network, including CMOs and alliances: Quality Lead for escalations and major investigations, quality oversight for regulatory filings, inspection readiness; leading platform-wide quality harmonization projects End-to-end product quality stewardship of biologics across the global network, including CMOs and alliances: Quality Lead for escalations and major investigations, quality oversight for regulatory filings, inspection readiness; leading platform-wide quality harmonization projects



Sandoz

• Switzerland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Program Manager QA Development Oncology

  • Jan 2016 - Dec 2016

  Managing all QA aspects of oncology development portfolio across multiple sites, covering GLP, GCP and GMP; driving the QA strategy for assigned portfolio; BD&L team member; responsible for inspection-readiness of bioanalytical laboratories

• Project Manager QA Development

  • Jun 2013 - Dec 2015

  QA Management across multiple development projects, ensuring that product design, development, and commercialization processes comply with cGLP, cGMP and cGCP requirements



MorphoSys

• Germany
• Biotechnology Research
• 300 - 400 Employee

• CMC Quality Manager

  • Jan 2010 - Apr 2013

  Established an interface between CMC, QA, RA and CMOs; Management of internal and external (CMOs and CROs) CMC-related QA and RA activities of all programs; creation of regulatory filing documentation; ensuring the release of clinical trial material, support of quality audits Established an interface between CMC, QA, RA and CMOs; Management of internal and external (CMOs and CROs) CMC-related QA and RA activities of all programs; creation of regulatory filing documentation; ensuring the release of clinical trial material, support of quality audits



Hexal

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Lab Head Quality Control

  • Apr 2006 - Dec 2009

  Leading a QC laboratory with 6 team members; release analysis of biotechnological pharmaceuticals; planning, conducting and evaluating stability studies; cooperation with internal and external partners

• Project Lead Biopharmaceutical Stablity Studies

  • Nov 2004 - Apr 2006

  Planning, conducting and evaluating biopharmaceutical stability studies, preparation of submission documentation and answers to deficiency letters (Module 3)



AMINO GmbH

• Germany
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Manager Quality Assurance

  • Feb 2003 - May 2005

  Documentation according to ISO and GxP standards, maintaining document repository, member of the QM team, validation of analytical methods, LIMS management

• Manager Quality Control

  • Jun 2004 - Nov 2004

  Managing QC lab with 15 team members, QC of incoming goods and products, equipment qualification, complaint management