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Hello, I am Thomas Starke, a quality and compliance professional with a strong background in integrated management systems, GMP, and regulatory affairs. I strive to harness cross-functional expertise to deliver robust solutions that support reliable product releases and compliant operations on both local and international scales. I am a curious, solution-oriented team player who thrives on challenging projects. I take ownership of initiatives, communicate clearly, and work across functions to implement fit-for-purpose actions that advance business objectives.…Hello, I am Thomas Starke, a quality and compliance professional with a strong background in integrated management systems, GMP, and regulatory affairs. I strive to harness cross-functional expertise to deliver robust solutions that support reliable product releases and compliant operations on both local and international scales. I am a curious, solution-oriented team player who thrives on challenging projects. I take ownership of initiatives, communicate clearly, and work across functions to implement fit-for-purpose actions that advance business objectives.

Thomas Starke

Project Manager, Studio Manager, Designer, +2

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Hello, I am Thomas Starke, a quality and compliance professional with a strong background in integrated management systems, GMP, and regulatory affairs. I strive to harness cross-functional expertise to deliver robust solutions that support reliable product releases and compliant operations on both local and international scales. I am a curious, solution-oriented team player who thrives on challenging projects. I take ownership of initiatives, communicate clearly, and work across functions to implement fit-for-purpose actions that advance business objectives.…Hello, I am Thomas Starke, a quality and compliance professional with a strong background in integrated management systems, GMP, and regulatory affairs. I strive to harness cross-functional expertise to deliver robust solutions that support reliable product releases and compliant operations on both local and international scales. I am a curious, solution-oriented team player who thrives on challenging projects. I take ownership of initiatives, communicate clearly, and work across functions to implement fit-for-purpose actions that advance business objectives.

Available to hire

Hello, I am Thomas Starke, a quality and compliance professional with a strong background in integrated management systems, GMP, and regulatory affairs. I strive to harness cross-functional expertise to deliver robust solutions that support reliable product releases and compliant operations on both local and international scales.

I am a curious, solution-oriented team player who thrives on challenging projects. I take ownership of initiatives, communicate clearly, and work across functions to implement fit-for-purpose actions that advance business objectives.

Language

German

Fluent

English

Fluent

Croatian

Fluent

Spanish; Castilian

Fluent

French

Advanced

Italian

Advanced

Work Experience

Quality Manager Stv. FvP / Deputy RP / Narcotics Officer at Mundipharma MMCO OBC

December 1, 2024 - Present

Strategic: Market release of medicinal products in Switzerland; Quality Assurance/System activities at MMCO; Pharmacovigilance and notification of adverse drug reactions to Swissmedic; liaison with Swissmedic on narcotics; quality issue management (counterfeits, adverse events); qualification and validation; supply chain responsibilities (market release, recalls); inspection management for CMOs and internal/external inspections; document and data management; CAPA/Change Control/Deviations; IMS/QEHS updates; archiving; stakeholder management; acting as Deputy RP per MMCO guidelines. Operational: prepare and participate in inspections; on-site QA decisions; collaborate with multiple sites; maintain compliance and readiness.

IMS Manager at GETEC Park

April 1, 2023 - March 31, 2024

From scratch, developed and maintained an Integrated Management System (IMS); defined responsibility matrices, topics, and to-do lists; authored and advanced the GETEC IMS Handbook as a prerequisite for ISO 9001 and 14001 audits; ensured ongoing alignment of QEHS policies with MSC and SCS guidelines; ongoing monitoring and updates.

PSTC Compliance Manager at F. Hoffmann-La Roche

January 1, 2021 - December 31, 2022

Coordinate internal audits and Gemba walks; manage OneQMS-PQS Veeva audit/inspection processes; authoring/updating GMP documents (audit/inspection SOPs) and PMS documents; acted as PST Coremap officer; supported audit/inspection processes and core programs.

Quality Systems Manager - Biotech Manufacturing (Bevacizumab) at F. Hoffmann-La Roche

January 1, 2012 - December 31, 2014

Established and implemented TrackWise CAPA tool for Pharma Quality Systems Basel Biotech Manufacturing; issued CAPA/DR/IR data reviews; managed quality documentation in English and German; led qualification/validation of laboratory instruments; maintained CSV for Labo software; archiving; drove change management and root-cause analysis (5 Whys, Ishikawa).

Global PEHS Expert and Product Steward at Huntsman AdMat Huntsman

January 1, 2009 - December 31, 2011

Managed raw material data (composition, properties, toxicology/ecotoxicology, labeling); liaised with internal/external stakeholders on EHS and raw material issues; trained in GHS/REACH classification; handled chemical safety reporting and toxicology data; coordinated data and labeling activities with product managers.

Postdoctoral Fellow in Neurophysiology at Universidad de Miguel Hernandez

January 1, 2007 - December 31, 2008

Research on thyroid hormones and cerebral cortex development; contributed to neurophysiology research programs.

Postdoctoral Fellow in Neurophysiology at Pennington Biomedical Research Center

January 1, 2006 - December 31, 2007

Investigated mechanical control by CNS on GI tract functions; contributed to neurophysiology research.

Postdoctoral Fellow in Molecular Biology at Université Paris-Sud

January 1, 2005 - December 31, 2006

Studied function and behavior of bacterial reaction center (QA/QB) in Rhodobacter sphaeroides; contributed to biochemical research.

Translator at ALD

January 1, 2018 - Present

Verbal and written translations from German to English, Croatian and Spanish and vice versa.

General Manager at AMKB

January 1, 2018 - December 31, 2019

Team leadership, project management, and oversight of construction-industry inspectorate activities in BL.

Global Issue Manager- GMP Specialist at F. Hoffmann-La Roche

January 1, 2014 - December 31, 2018

Acquire quality and legal documents to compile dossiers for international submissions (releases, tenders, launches, license renewals); Roche Global Networking Excellence; manage GMP-related data; founding member of Roche Global Interface Portal project; facilitate GET meetings for counterfeits; write TWIMCs for counterfeit cases.