10/26/2026 updated

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GxP Quality Manager, Regulatory Affairs Manager, Project Manager

Alhaurín de la Torre (Málaga), Spain
Germany +9
info: Germany, Austria, Switzerland, Spain, Italy, France, Denmark, Netherlands, Poland, Portugal
Chemie mit Promotion; Psychologie M.Sc.
Alhaurín de la Torre (Málaga), Spain
Germany +9
info: Germany, Austria, Switzerland, Spain, Italy, France, Denmark, Netherlands, Poland, Portugal
Chemie mit Promotion; Psychologie M.Sc.

Medizintechnik / Pharma Projekt Management (Europa, USA, Japan), Qualitätsmanagement, GMP Guidelines und Gesetze z.B.: AMWHV, EU-GMP Leitfaden, ICH Guidelines und FDA/USA 21 CFR 4, 11, 210/211, 820; MEDDEV / MDCG, MPG / MPDG, MDD, 93/42/EWG, MDR/IVDR 2017/745-746; MDSAP; Gebrauchstauglichkeit (Usability / Human Factors and Usability Engineering gemäß IEC 62366 / FDA CDRH); DIN EN ISO 13485:2012/2016; Audits / Inspektionen z.B. durch die FDA; Regulatory Affairs, z.B.: Medical Devices (510(k), ehem. STED Format), Pharma CMC Part – Modul 3, Combination Products / Companion Products, Phyto-Pharmazeutika, z.B., Zulassung in Deutschland, Europa, USA, Japan, Korea, Canada, Australien, Brasilien; Arbeits- und Organisationspsychologie, Kommunikation, Stress-Management Schulungen, Auditpsychologie und Audit Schulung für Mitarbeiter / Auditoren, firmeninterne Schulungen & Dozentin für Qualitätsmanagement.

Experience

Professional experience10+ years
Freelancer since2006

Languages

GermanNative speakerEnglishFluentFrenchBasic knowledgeSpanishGood

Project history

Quality Management: Consultant and hands-on support

I: Medical devices (implants), global company: Hands-on support QM and optimization strategy & implementation for the QM system, e.g., writing SOPs, processing of CAPA, SME in corp audits; Test Method Validation, e.g., XRD according to ICH Q2(R2) and MSA Measurement System Analysis (six sigma)
II: Test method implementation: IQ/OQ for test equipment and TMV for a complex analytical method

Quality Management: Consultant, Trainer and hands-on support

Hands-on support and optimization strategy for the QM system, e.g., writing SOPs like CAPA, reprocessing/reworking, risk management, performing trainings, for a global API, Excipient, Cosmetics, Nutrition etc. manufacturer and CDMO/CMO. Trainings on QM

GMP Compliance & Documentation

anonym

Pharmaceuticals & Medical Technology

< 10 team member

Support QM/QS for an Advanced Therapy Medicinal Product (ATMP) manufacturer start-up, before inspection by competent authority to receive manufacturing authorization according to §13 AMG; including writing/review/comments of answers to deficiency letters, documents, trainings

Quality Management; Regulatory / CMC

anonym

Pharmaceuticals & Medical Technology

50-250 team member

Compilation of an FDA Master File, ATMP

Quality Management

anonym

Pharmaceuticals & Medical Technology

5000-10.000 team member

Concept and implementation of an evaluation system for reprocessing of reusable medical devices (cf. FDA
„Guidance Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling“; ISO
17664:2017; Recommendation from the Commission on Hospital Hygiene and Infection Protection at the
Robert Koch Institute (RKI) and the Federal Institute for Drugs and Medical Devices (BfArM) on the "Hygiene
requirements for the reprocessing of medical devices"), MDR readiness, authoring of scientific / literaturebased
Peer Reviews, Reporting; Biocompatibility Assessment for Implants. Biocompatibility Evaluations
(extractables/leachables), according to ISO 10933 for a series for polymer implants, together with a
toxicologist, including interpretation of MS spectra measured by a contract lab (evaluation reports); answering
deficiency letters of notified body.

Quality Management; Regulatory / CMC; Organizational Change Management

anonym

Pharmaceuticals & Medical Technology

>10.000 team member

Gap-analysis and optimization of QM system, with regard to FDA / IVDR readiness (Medical Device
manufacturer); support URS, selection process and customizing of new CAPA software and procedure;
supporting preparation of 510(k) documents and technical documentation, Intended Use (Product Claim) acc.
to IVDR / MDR Article 7 for various products; application of IVDR/MDR rules for correct registration according
to Product Claim and advice regarding content of IFU, labelling; conducting online-trainings on QM topics and
internal audits according to ISO 13485:2016; project lead and final project evaluation (questionnaire)

Quality Management

anonym

Pharmaceuticals & Medical Technology

50-250 team member

Concept and implementation of a QM System for a Pharmaceutical Entrepreneur / Distributor, preparation of a
tailored Quality Manual, SOPs, Supplier / Contract manufacturer Audits, Regulatory Audits, GDP, responsible
external QM Manager, communication with local authorities.
Audits, due to Corona pandemic remote audits:
  • 06/2020: contract manufacturer qualification as document & online audit (manufacturer, regulatory, QM
  • and general services)
  • 09/2020: contract manufacturer qualification as document audit & video audit (manufacturer in France,
  • GMP/GDP)
  • 11/2020: contract manufacturer qualification as document & video audit (archiving service)
  • 04/2021: contract manufacturer qualification as document & video audit (logistics, GDP)
  • 06/2021: selection process and qualification by questionnaire of pharmacovigilance contract service
  • provider
  • 06/2021: contract manufacturer qualification as online/video audit (manufacturer, GMP)
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