fda Jobs in Basel

Fraser Dove International seeks a Quality Control professional to join its GMP-focused Basel operation. The role acts as a senior SME, leading FDA PAI readiness, regulatory inspections, and analytical method transfer across QC, QA, MSAT, Validation and Regulatory Affairs.You will drive CAPA, data integrity, and lifecycle management to ensure compliant...

Techfirm Engineering in Basel is seeking a QA / Qualification engineer to lead CQV activities for equipment, utilities and cleanrooms in pharma/biotech projects.You will review URS, risk assessments, test plans, deviations and change controls, and ensure GMP/FDA compliance while collaborating with Engineering, Operations and vendors.German language is...

We’re supporting a leading global biopharmaceutical manufacturing organisation with the appointment of an experienced Quality Control professional to strengthen its Pre-Approval Inspection (PAI) readiness, analytical method transfer and QC compliance capabilities.This is a highly visible role within a complex GMP manufacturing environment, working across...

Monte Rosa Therapeutics seeks a seasoned Associate Director of CMC Regulatory Affairs to shape global CMC strategy and author critical submission content. You will collaborate with Process Chemistry, Analytical Development, Drug Product, Quality, and Clinical Supply to ensure compliant, high-quality filings.You will drive Module 3 content, quality summaries,...

pClinilabs is seeking a Global Project Manager to oversee cross-functional, multi-regional CNS clinical trials from protocol concept to final study report, ensuring timelines, budget and quality. /ppYou will lead client communications, vendor management and risk mitigation, collaborate with regulatory, data management and medical science teams, and drive...

Headcount is seeking a Director of Regulatory Affairs CMC Europe to lead the regulatory strategy for novel small-molecule therapies in oncology. This role requires steering global CMC development, submissions and lifecycle management across clinical, regulatory and manufacturing functions, with a focus on Module 3 and interactions with FDA/EMA.The candidate...

ppNotre client, une entreprise biopharmaceutique internationale basée à Bâle, développe et fabrique des biologics et petites molécules pour des marchés soumis à EU/FDA/Swissmedic. Pour renforcer l’équipe Regulatory CMC, nous recherchons un(e) Responsable Affaires Réglementaires CMC capable de piloter la stratégie dossier de la clinique au...

OverviewMonte Rosa Therapeutics is seeking a highly skilled and self-motivated regulatory professional to join our team as an Associate Director of CMC Regulatory Affairs. The CMC Regulatory Affairs will serve as a key regulatory strategist and author for the Chemistry, Manufacturing, and Controls components of Monte Rosa's global regulatory filings. This...

STELLENVAKANZ AUSGANGSLAGE:Für unseren Kunden, ein international tätiges Engineering-Unternehmen mit Fokus auf die Life-Science-Industrie, suchen wir eine erfahrene Persönlichkeit als Senior Projektleiter Gebäudetechnik HKLS (m/w/d). Sie übernehmen eine zentrale Rolle bei anspruchsvollen Pharma- und Biotech-Projekten und verantworten die Gewerke...

Director, Regulatory Affairs CMC Europe Ready to lead the CMC regulatory strategy for novel small-molecule therapies in oncology? We’re partnering with an innovative biotechnology company that is advancing a portfolio of next-generation targeted oncology therapies. As the pipeline progresses towards global registrations, we’re looking for an experienced...

Manpower Switzerland in Basel sucht eine erfahrene Fachkraft für Compliance im klinischen Umfeld. Die Rolle sichert GxP-/Qualitätsanforderungen und koordiniert Audit- und Regulierungsprozesse in der globalen Clinical Distribution.Sie beraten Fachbereiche, bearbeiten Deviations, CAPAs und Change Controls, führen RCA durch und begleiten Audits (FDA/EMA)....

GxP Compliance Experts sucht ab sofort eine/n GxP Compliance Expert/in für einen internationalen Auftraggeber mit Sitz in Basel.Sie fungieren als SME für GxP- und Compliance-Themen, betreuen Audits/Inspektionen (FDA/EMA/PTQ) und arbeiten an CAPAs, Abweichungen sowie SOP-Management. Sie verfügen über einen Hochschulabschluss und mehrjährige...

ppWir sind ein junges, dynamisches Consulting-Unternehmen mit Fokus auf die Life-Science-Industrie und arbeiten täglich an hochwertigen, praxisnahen Lösungen für unsere Kundinnen und Kunden. /ppWir bieten fundiertes Engineering-Quality-Know-how für die Implementierung oder Verbesserung des gesamten technischen Qualitätskonzepts in der...

About Us ten23 health is a human-centric and sustainable strategic partner of choice for the pharmaceutical industry and biotech start-ups for the development, manufacture, and testing of tomorrow’s medicines. We support our clients in developing differentiated, stable, usable, and safe injectable treatments for patients. Your mission Location: BaselFTE:...

Artidis is a Basel-based health technology company seeking a senior Mechanical Engineer to lead the design, prototyping, and industrialization of our tissue-analysis devices. You will collaborate with hardware, embedded and software teams to translate concepts into robust hardware ready for manufacturing.The role requires strong experience with ISO...

As a Data Engineer, you will build and implement the core data, ML, and deployment infrastructure that enables scalable, reproducible, and traceable machine learning systems for use in clinical diagnostics. In addition, your code will ensure the traceability and quality of all digitized data from ingestion to research, model development, clinical validation,...

As the founding Machine Learning Engineer, you will lead the development of the core algorithms powering Moonlight’s AI platform. This high-impact role drives execution of the R&D roadmap, sitting at the intersection of computer vision, engineering, and product development. Responsibilities: Develop, validate, and document deep learning algorithms to...

ppbSenior QA Expert for QC – 7084 URA /b /ppOur client, a global market leader in the production and process support of active pharmaceutical ingredients, both in the chemical and biotechnology sectors, is looking for a bSenior QA Expert for QC /bThe Sr. QA Expert for QC role is a 6M contract with b60% workload /b. QA responsible for QC oversight to...

💊 Ingénieur Affaires Réglementaires Pharma – Qualité & Fabrication du médicament (F/H) 📍 Suisse Avant qu'un médicament arrive chez les patients, il faut prouver qu'il est bien fabriqué, bien contrôlé et sûr. Et si c'était toi qui constituais cette preuve ? L'entreprise QUI SOMMES NOUS ? CLEEVEN, cabinet de conseil en ingénierie à...

Switzerland, Basel Switzerland, Stein The actual location of this job is in Stein, AG, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed. Take ownership of complex inspections and customer audits by coordinating preparation, managing stakeholders, hosting auditors, and driving successful outcomes across two...