19.04.2026 aktualisiert
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Quality Assurance, MSAT & Regulatory Compliance Executive
Frasnacht, Schweiz
Weltweit
PhD in Pharmaceutical TechnologyÜber mich
Quality Assurance, MSAT & Regulatory Compliance Executive, fvP and EU-QP
Skills
ComplianceMedikamentenverwaltungsprozessMSAT
Quality Assurance & Quality Systems
Expertise in establishing effective quality management systems and regulatory compliance across biotech drug substance production and process enhancement.
Process Validation & Resource Optimization
Proficiency in crafting and implementing GMP and regulatory strategies for FDA clearance and global approvals with strong leadership in process validation.
Leadership & Strategic Planning
Strong leadership demonstrated in process validation, resource management, and strategic planning for operational optimization.
m-RNA Drug Substance Production
Specialized knowledge in biotech drug substance production and process enhancement with focus on m-RNA manufacturing.
Technical Transfers & Scalability
Experience in managing technical transfers, scalability initiatives, and process controls to ensure efficiency.
Regulatory Submissions
Collaborative approach in engaging stakeholders, drafting regulatory dossier segments, and facilitating timely submissions.
Process Optimization
Skills in process optimization and regulatory submissions with focus on aseptic processing and packaging.
GMP and GDP Compliance
Comprehensive understanding of Good Manufacturing Practice and Good Distribution Practice requirements.
Expertise in establishing effective quality management systems and regulatory compliance across biotech drug substance production and process enhancement.
Process Validation & Resource Optimization
Proficiency in crafting and implementing GMP and regulatory strategies for FDA clearance and global approvals with strong leadership in process validation.
Leadership & Strategic Planning
Strong leadership demonstrated in process validation, resource management, and strategic planning for operational optimization.
m-RNA Drug Substance Production
Specialized knowledge in biotech drug substance production and process enhancement with focus on m-RNA manufacturing.
Technical Transfers & Scalability
Experience in managing technical transfers, scalability initiatives, and process controls to ensure efficiency.
Regulatory Submissions
Collaborative approach in engaging stakeholders, drafting regulatory dossier segments, and facilitating timely submissions.
Process Optimization
Skills in process optimization and regulatory submissions with focus on aseptic processing and packaging.
GMP and GDP Compliance
Comprehensive understanding of Good Manufacturing Practice and Good Distribution Practice requirements.
Erfahrung
Berufserfahrungmehr als 10 Jahre
Freelancer seit2013
Sprachen
DeutschMutterspracheEnglischverhandlungssicher
Projekthistorie
Head of Manufacturing in a re-structuring transition phase. Lead manufacturing, procurement and production planning personnel to manufacture solid dosage forms, resulting in timely supply of global clinical studies. Implemented and streamlined new packaging technology into production.
QP for STADA Arzneimittel AG, STADAPHARM GmbH, ALIUD PHARMA GmbH and Hemopharm GmbH, DE-Bad Vilbel; QP for Regenaplex GmbH, DE-Konstanz; fvP for Gelpell AG, CH-Gähwil; fvP for Ai Fame GmbH (now Schibano Pharma AG), CH-Schönengrund; fvP for Zeller AG, CH-Romanshorn
Oversee process tech transfer, scalability, and PPQ for m-RNA manufacturing facility greenfield project to ensure manufacturability of m-RNA drug substance. Provide technical support for technical and GMP batches to assist in preparation for manufacturing license audits.