19.10.2026 aktualisiert
100 % verfügbar
Senior Quality Management Professional | Pharmaceutical & Biotech QA Expert
Bedburg-hau, Deutschland
Weltweit
BSc Farmakunde / Pharmaceutical Sciences, University of Applied Sciences Utrecht (NL), 2011-2015Über mich
Independent Senior QA & GxP Consultant specializing in GMP, QMS, RCA investigations, and batch release for pharma and biotech. Former Senior QA Manager advancing executive leadership at Harvard University. Registered German Freiberufler (USt-IdNr available) for EU and global interim consulting.
Skills
GMP & Pharmaceutical Quality Assurance
Nearly 15 years of deep technical expertise in complex pharmaceutical environments, including GMP, sterile manufacturing (Annex 1), API processes, and advanced deviation/CAPA systems. Extensive experience with EU GMP Annex 1, 21 CFR 210/211, and ICH guidelines, as well as QMS/SOP drafting and complex deviation/OOS root cause investigations.
People Management & GxP Training
Cross-functional leadership of QA/DEV/OPS teams with personal design, coordination, and execution of advanced GxP training programs. Mentoring and training of over 160 professionals in classroom and individual settings, steering site-wide Quality Culture.
Multi-Sector Compliance & Project Management (GMP/ISO)
Direct QA project management and oversight for international clients, achieving successful compliance with GMP and ISO (9001 and 22716) standards. End-to-end project management for key international commercial accounts, including high-profile clients in the pharmaceutical and cosmetics sectors.
Root Cause Investigation & CAPA Management
Proven track record in managing complex root cause investigations, OOS/OOE/OOT events, deviations, complaints, and recalls, ensuring robust risk mitigation and defensible quality decisions.
Regulatory Inspection Readiness
Extensive experience managing regulatory authority inspections (FDA/IGJ) and steering inspection readiness platforms and self-inspections for major pharmaceutical and biotech organizations.
QP Delegate & Batch Release Operations
Formal QP Delegate experience responsible for strict compliance and regulatory release of media, Drug Intermediates, and Drug Substances. Compilation and review of comprehensive release files for final Drug Products.
Corporate Governance & Financial Insight
Active Works Council Member advising the Executive Leadership Team (ELT) on strategic initiatives, organizational changes, and high-level financial governance based on specialized corporate finance training (SBI Formaat).
Quality Management Systems (TrackWise, MasterControl)
Hands-on experience reviewing and authorizing high-stakes Quality Records in TrackWise and MasterControl, administering Quality KPIs for corporate dashboards, and authoring Product Quality Reviews (PQRs).
B2B Consulting & Fractional QA Support
Providing independent, high-level Quality Assurance and compliance support for international biopharmaceutical and CDMO clients on a flexible project/hourly basis, including BPR reviews, release file compilation, and QMS/SOP drafting.
Nearly 15 years of deep technical expertise in complex pharmaceutical environments, including GMP, sterile manufacturing (Annex 1), API processes, and advanced deviation/CAPA systems. Extensive experience with EU GMP Annex 1, 21 CFR 210/211, and ICH guidelines, as well as QMS/SOP drafting and complex deviation/OOS root cause investigations.
People Management & GxP Training
Cross-functional leadership of QA/DEV/OPS teams with personal design, coordination, and execution of advanced GxP training programs. Mentoring and training of over 160 professionals in classroom and individual settings, steering site-wide Quality Culture.
Multi-Sector Compliance & Project Management (GMP/ISO)
Direct QA project management and oversight for international clients, achieving successful compliance with GMP and ISO (9001 and 22716) standards. End-to-end project management for key international commercial accounts, including high-profile clients in the pharmaceutical and cosmetics sectors.
Root Cause Investigation & CAPA Management
Proven track record in managing complex root cause investigations, OOS/OOE/OOT events, deviations, complaints, and recalls, ensuring robust risk mitigation and defensible quality decisions.
Regulatory Inspection Readiness
Extensive experience managing regulatory authority inspections (FDA/IGJ) and steering inspection readiness platforms and self-inspections for major pharmaceutical and biotech organizations.
QP Delegate & Batch Release Operations
Formal QP Delegate experience responsible for strict compliance and regulatory release of media, Drug Intermediates, and Drug Substances. Compilation and review of comprehensive release files for final Drug Products.
Corporate Governance & Financial Insight
Active Works Council Member advising the Executive Leadership Team (ELT) on strategic initiatives, organizational changes, and high-level financial governance based on specialized corporate finance training (SBI Formaat).
Quality Management Systems (TrackWise, MasterControl)
Hands-on experience reviewing and authorizing high-stakes Quality Records in TrackWise and MasterControl, administering Quality KPIs for corporate dashboards, and authoring Product Quality Reviews (PQRs).
B2B Consulting & Fractional QA Support
Providing independent, high-level Quality Assurance and compliance support for international biopharmaceutical and CDMO clients on a flexible project/hourly basis, including BPR reviews, release file compilation, and QMS/SOP drafting.
Erfahrung
Berufserfahrungmehr als 10 Jahre
Freelancer seit2026
Sprachen
DeutschgutEnglischverhandlungssicherNiederländischverhandlungssicher
Projekthistorie
Providing independent, high-level Quality Assurance and compliance support for international biopharmaceutical and CDMO clients on a flexible project/hourly basis. Core services include end-to-end executed/pre-executed Batch Production Record (BPR) reviews, release file compilation, complex deviation/OOS root cause investigations, CAPA management, and QMS/SOP drafting in compliance with EU GMP Annex 1, 21 CFR 210/211, and ICH guidelines.
Fostered a high-performance, site-wide Quality Culture by cross-functionally leading QA, Development, and Operations teams. Designed, coordinated, and executed advanced GXP training programs, mentoring over 160 employees. Provided strategic QA oversight and end-to-end project management for key international commercial accounts including PharmaResearch, Parvus, Peptinovo, and Ferronova. Selected as Finance Committee Representative within the Works Council. Owned the site Quality Management Review metrics and led complex investigations, deviations, CAPAs, complaints, OOS, OOT, and recalls.
Served as primary Quality contact for critical operations, reviewing and authorizing high-stakes Quality Records in TrackWise and MasterControl. Investigated, coordinated, and resolved complex cross-functional deviations and OOS/OOE/OOT events under tight operational timelines. Managed robust client and vendor relationships, steering regulatory inspection readiness platforms and self-inspections.