Dipl.-Ing. Jürgen Waditschatka
Selbstständig, Managing Director EPU, DI (FH) Jürgen Waditschatka - Life Science Consulting Services
Stockerau, Österreich
Über mich
As a result-oriented and versatile leader I offer holistic and personalised leadership, proven track record, and deep understanding of operations and best practices in the pharma/biotech/chemical industry. I accompany my partners with a reliable commitment to overcome obstacles on the way towards of highest standard of process/product/project/service quality, cost adherence, & timely patient delivery. I look forward to a long-term leadership opportunity where I can raise & connect the full potential of teams to strengthen collaboration, foster growth, drive operation, implement/transfer strategic processes/technology, assure CMC regulatory & IND/MAA compliance, improve resource efficiency, & enhance profitability. I work in flexible settings with a quick sense of business needs to rapidly interpret complex situations, formulate innovative solutions, make sound decisions, move strategic performance goals forward by esteeming diversity and equity and promoting inclusion and belonging.
Werdegang
Berufserfahrung von Jürgen Waditschatka
Bis heute 3 Jahre und 3 Monate, seit März 2021
Managing Director EPU
DI (FH) Jürgen Waditschatka - Life Science Consulting Services
Interim Manager e.g., Program-/Project-/Product-Lead, Operations Lead • End-to-end business consulting to support my partners in the areas of Development, Manufacturing, Quality, Science & Technology, Regulatory Affairs (i.e. MAA & e-CTD Excellence), Business Development, Operational Excellence, Supplier Relationship, and CMO Alliance Management
12 Jahre und 5 Monate, Sep. 2011 - Jan. 2024
Lector (part-time – annually during the winter semester)
FH Campus Wien
GMP and CMC regulatory compliance • eCTD dossier content requirements of a drug marketing authorisation application
1 Jahr, März 2022 - Feb. 2023
Senior Program Manager and CMC Expert • COVID-19 vaccine
Valneva
Program and alliance management of COVID-19 vaccine for adult & paediatric use; Support late-stage development, tech-transfer and transition into commercial operations
1 Jahr und 5 Monate, Okt. 2019 - Feb. 2021
Head of quality and regulatory compliance team Austria • Senior Consultant
BakerHicksEngineering, CQV & QMS consulting at Takeda, Cytiva and Boehringer Ingelheim Business development, CQV operational excellence, coaching, and mentoring
7 Monate, Okt. 2018 - Apr. 2019
Head of quality systems & GMP compliance, associate director
MSD Animal Health Danube Biotech GmbH
Regulatory and Quality Management Systems, DDMS, audit and inspection, commissioning, qualification & validation
2 Jahre und 2 Monate, Aug. 2016 - Sep. 2018
Product Lead • Chemistry - Manufacturing - Control
AOP Orphan Pharmaceuticals AGLeading GMP and submission data compliance strategy during late-stage development and transition to commercialisation in an international contract manufacturing and testing environment; Successful EMA approval of a PEGylated interferon and dossier variation and renewal of multiple chemical drugs
3 Jahre und 4 Monate, Apr. 2013 - Juli 2016
Global Head of Quality Product Owner • hemophilia pharmaceuticals
Baxter AG
2 Jahre und 8 Monate, Aug. 2010 - März 2013
Global Quality Product Owner • hemophilia & critical care pharmaceuticals
Baxter AG
3 Jahre und 3 Monate, Mai 2007 - Juli 2010
Global Subject Matter Expert • GMP compliance and drug licensing
Baxter AG
3 Jahre und 5 Monate, Dez. 2003 - Apr. 2007
Team Lead • media preparation
Baxter AG
3 Jahre und 2 Monate, Okt. 2000 - Nov. 2003
Team Lead • antigen purification FSME vaccine
Baxter AG
1 Jahr und 3 Monate, Juli 1999 - Sep. 2000
Project Manager • up- & down-stream process FSME vaccine
Baxter AG
1988 - 2000
Handball athlete • semi-professional
UHC Stockerau
9 Monate, Nov. 1998 - Juli 1999
Food Technology Engineer
Inzersdorfer Nahrungsmittelwerke
Ausbildung von Jürgen Waditschatka
4 Jahre, Sep. 2005 - Aug. 2009
Bioengineering
FH Campus Wien
major in quality management and regulatory compliance (e.g., marketing authorisation, GMP, quality assurance and control) of life science products
4 Jahre und 10 Monate, Sep. 1992 - Juni 1997
Food Technology
Private school for higher technical education
Food Technology, specialized in meat processing and quality control
Sprachen
Deutsch
Muttersprache
Englisch
Fließend