Jutta Lehmann

Angestellt, VP, Head of Global Quality Idorsia Pharmaceuticals Ltd ·, Idorsia Pharmaceuticals Ltd

Basel, Schweiz

Fähigkeiten und Kenntnisse

Total Quality Management (TQM)
IMP & Commercial
Systemic Business Coaching
FDA
US
Compliance
Pharmazeutin
Qualified Person
Regulatory Compliance
IMP
EU
DMAIC
continuous improvement
Quality assurance
Prozessoptimierung
Projektmanagement
expertise in small and large parenterals
Sterilproduktion
CMO
Coaching
Business Coaching
Change Control
Qualitätsmanagement
Leadership
Issue Management
CAPA
Validation
Qualitätssicherung
Quality Systems
Biotech
Inspections
Inspektionen
Clinical Trial Directive
Change Management
Annex 16
Quality Site Head
GMP
commercial launch worldwide
Pharmazie
Personalführung
Strategieentwicklung
Englische Sprache
SOP
GMP Compliance
Führungserfahrung
strategisch
Erfahrung
Feed
Food
Supplier Management
QP
Supply Chain
Deutsch
Organisationsentwicklung

Werdegang

Berufserfahrung von Jutta Lehmann

  • Bis heute 2 Jahre und 7 Monate, seit Okt. 2021

    VP, Head of Global Quality Idorsia Pharmaceuticals Ltd ·

    Idorsia Pharmaceuticals Ltd

    • Responsible for the overall supervision of GxP Team Leaders, QA Managers as appointed to manage and monitor compliance and quality standards within specific GxP/ regulatory areas including GLP, GMP, GDP, GCP, GPV, CSV and PV, commercial launches worldwide and maintaining a high-quality standard balanced with business needs • Liaise with Health Authorities in all quality related matters as reportable product quality incidents or recalls

  • 1 Jahr und 10 Monate, Dez. 2019 - Sep. 2021

    Head of Quality

    DSM Nutritional Products

  • 2 Jahre und 10 Monate, Feb. 2017 - Nov. 2019

    Head of External Quality S&O

    F. Hoffmann- La Roche

    - Lead the External Quality Systems and Operations Organization in External Quality. - Accountable for implementation, realization and maintenance of a Pharmaceutical Quality System as applicable to CMOs - Accountable for establishing and conducting Quality Governance within External Quality - Responsible for Release of products manufactured at Contract Manufacturing Organisations - Accountable for the Validation team supporting qualification and validation activities at CMO`s

  • 2 Jahre und 11 Monate, Apr. 2014 - Feb. 2017

    Head of Pharma Quality Marketed Products

    Roche Pharma AG Grenzach

    15 years of experience in different companies and areas such as Quality (commercial and IMPs), Business operations, Finance/IT and Supply Chain. 10+ years proven leadership skills, Coaching expertise. Results and success driven. Excellent negotiation and change management skills. Broad business acumen. Wide experience in international and compliance projects. Pharmacist by education, QP and certified Coach within the European Coaching Academy.

  • 3 Jahre, Mai 2011 - Apr. 2014

    Head of Data Quality Management

    Roche Pharma AG

  • 3 Jahre, Mai 2008 - Apr. 2011

    Head of PQIE (Quality for IMPs)

    Roche Pharma AG

  • 4 Jahre und 2 Monate, Feb. 2002 - März 2006

    Head of GMP Compliance

    Essex- Division of Schering Plough

    Head of GMP Compliance

Ausbildung von Jutta Lehmann

  • Pharmazie

    Martin- Luther Universität Halle

Sprachen

  • Deutsch

    -

  • Englisch

    -

  • Französisch

    -

Interessen

Tennis
Kinder; Volleyball

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