
Jennifer Hesse
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About me
Compliance Lead I GxP I People Lead I Coach I Logistics I Distribution I Quality Manager I Inspection & Audit Management
Education

Technische Universität Dortmund
2008 - 2011Master of Science (MS) BiochemistryThe study deals with the chemical processes in biological systems, and highlights specific issues in the border area between chemistry and biology produce - for example, the chemical synthesis of biologically active substances, or the development of biosensors specific chemical modification of biomolecules.

Technische Universität Dortmund
2004 - 2008Bachelor of Science (BS) BiochemistryThe study deals with the chemical processes in biological systems, and highlights specific issues in the border area between chemistry and biology produce - for example, the chemical synthesis of biologically active substances, or the development of biosensors specific chemical modification of biomolecules.
Experience

TOP Nachhilfe
Feb 2011 - Oct 2011Private tutorPrivate tutor for the subjects chemistry and biology

Service am Gast GmbH
Nov 2011 - Apr 2012Consultant for conference supportConsultant for conference support at Henkel AG & Co. KGaA (Düsseldorf)

EPetWorld GmbH
May 2012 - Aug 2012Customer Service Agent- Head of Customer Service - Operations Management - Management of external service providers (e.g. fulfillment service providers, payment providers, dropshippers)- Design/implementation of processes (e.g., customer service, logistics, front-end and back-end)- Definition, collection, evaluation and reporting of key figures - Support of newsletter marketing

DORMA
Sept 2012 - Feb 2013Employee idea management (temporary)- Revision and standardization of documents (SOPs) and processes after ISO 9001- Supervision and maintenance of the continuous improvement program- Maintenance and further development of quality indicators (KPIs)- Development and analysis of statistics

LVQ Weiterbildung gGmbH
Mar 2013 - Aug 2013Further education: Quality Manager, Health and Safety Manager, Environmental ManagerFull-time education: Quality Manager, Health and Safety Manager, Environmental Manager; Including Water Protection Officer, Pollution Control Officer, Waste Management Officer

Adviselynx AG
Feb 2014 - Dec 2015Quality Manager- Establishment and further development of the quality management system- Establishment of the training management and execution of training courses- Document management- Providing quality and compliance services to pharmaceutical companies and software suppliers:- Quality Consultant @Roche: Document Management- Quality Consulant @Novartis: - Preparation, coordination and monitoring / support of customer and regulatory audits as well as self-inspections (GxP, SOX)- Risk, Issue and Action Management- Computer System Validation (CSV)- Assists the project/program PMO in coordinating project activities and decision-making Show less

Roche
Jan 2016 - nowLeading a team responsible for GxP Support for Site Logistics including Roche Global Warehouse - Supervision of inspections (authorities, customers)- Conducting self-inspections- Coordination, documentation, tracking and archiving of inspections- Ensuring inspection readiness at the site with respect to regulatory requirements- Coordination and Maintenance of quality management concept and the departmental SOPs- Monitoring of GMP standards regarding regulatory and internal requirements- Conducting training in the field of inspection management
Head GxP Compliance
Apr 2023 - nowQA Manager for Logistics
May 2022 - Apr 2023Quality Compliance Manager
Jan 2016 - Apr 2022
Licenses & Certifications

GMP Auditor
Jun 2017
Qualitätsbeauftragte
TÜV Rheinland GroupApr 2013
Lean Six Sigma - Yellow Belt
RocheMar 2019
Umweltbetriebsprüferin (einschließl. Gewässerschutzbeauftragte, Immissionsschutzbeauftragte, Abfallbeauftragte)
LVQ Weiterbildung gGmbHMay 2013
ITIL v3 Foundation
AXELOS Global Best PracticeMay 2014
GMP
CONCEPT HEIDELBERG GmbHAug 2015
Regulatory Compliance Expert
CONCEPT HEIDELBERG GmbHOct 2018
Fachkraft für Arbeitssicherheit
Mplus Managementgesellschaft zur Optimierung von Arbeitsbedingungen mbHAug 2013
Languages
- deDeutsch
- enEnglisch
- frFranzösisch
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