gcp quality

Als Spezialist in der Verdauungs- und Stoffwechselmedizin und Familienunternehmen mit globaler Vernetzung, setzen wir unseren Fokus auf die Entwicklung und den Vertrieb innovativer Arzneimittel für verschiedene Erkrankungen der Leber, der Gallenwege, des Darms und der Speiseröhre, um das Leben von Menschen zu verbessern. Wir glauben daran, dass wir nur...

Responsibilities Leads GCP quality oversight for global clinical program(s) to ensure sustained compliance, inspection readiness across internal teams. Implements standards for risk-based oversight, issue management rigor, translating quality signals into cross-functional actions that protect participants and data integrity. Oversees quality performance...

The Director, Quality Assurance is responsible for quality operations and regulatory compliance; works through others to achieve organizational quality and compliance goals and works closely together with the international Quality and Regulatory Services department.      Please note: this role is best suited for candidates local to Cologne. The...

Merz Aesthetics is an independent, internationally active company in the field of aesthetic medicine. For years, our comprehensive product portfolio is among the highest quality in its category and is valued by healthcare professionals worldwide. Merz Aesthetics is part of the Merz Group, with our Europe , Middle East and Africa (EMEA) headquarters in...

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.Each of us, no matter what we do at...

Merz Aesthetics is an independent, internationally active company in the field of aesthetic medicine. For years, our comprehensive product portfolio is among the highest quality in its category and is valued by healthcare professionals worldwide. Merz Aesthetics is part of the Merz Group, with our Europe , Middle East and Africa (EMEA) headquarters in...

Global Head of Quality Systems (m/f/d)BaselBerlin Greifswald RemoteWe are an owner-managed, globally active company in the specialty pharmaceuticals sector with a clear mission: to be THE sustainable platform for long-established and trusted pharmaceutical brand products in various therapeutic areas. As a reliable partner to the research-based pharmaceutical...

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.The Senior Manager R&D Quality Analytics & Portfolio...

Nothing provides more motivation than success. Da Vinci Engineering is highly committed to ensuring the own employees' success. Become a part of us! Senior Auditor / R&D Quality Manager (m/f/d) Stellen-ID: 22169 Standort: Frankfurt am Main We are searching intelligent and innovative employees. If you are interested in working for a dynamic company with...

Als Quality Manager Corporate Systems & Projects (m/w/d) übernimmst du eine verantwortungsvolle Rolle innerhalb der Global Quality Unit und leisten einen wesentlichen Beitrag zur Weiterentwicklung und Optimierung des Pharmazeutischen Qualitätssystems (PQS) der HELM Pharmaceuticals GmbH.In internationalen und interdisziplinären Projektteams vertrittst du...

About usWe’re Cortea, a Berlin startup transforming audits with AI. Manual, document-heavy audits waste expert time while demand keeps rising. Our AI-powered software and specialized AI agents remove the repetitive work so auditors can focus on judgment.Backed by top-tier VCs with >15m EUR funding, with a working product and paying customers, we’re...

We are an owner-managed, globally active company in the specialty pharmaceuticals sector with a clear mission: to be THE sustainable platform for long-established and trusted pharmaceutical brand products in various therapeutic areas. As a reliable partner to the research-based pharmaceutical industry, CHEPLAPHARM ensures the availability and supply of these...

Aufgaben Analyse und Migration bestehender ETL-Prozesse: Analyse und technische Bewertung der bestehenden Informatica-PowerCenter-Mappings und -Workflows sowie der relevanten Oracle-Datenbankobjekte und Überführung der bestehenden ETL-Logik in BigQuery SQL und Dataform einschließlich Entwicklung von Dataform-Modellen, Einsatz KI-gestützter Verfahren zur...

About This Role   Veranex is excited to offer an opportunity to join our growing Clinical Operations team as a Senior Clinical Research Associate (Sr CRA). In this role, you will support innovative medical device studies across Germany and potentially throughout Europe. You will play a critical role in ensuring the high-quality execution of clinical...

Role Details - Sub InvestigatorTwo openings are available:12‐month contract - 0.6 FTE+Permanent position - Full timeFully on siteLocated North-East of HamburgAbout the OpportunityA leading clinical research organisation are looking for a Sub Investigator to support ongoing clinical trials at their site located North-East of Hamburg. This is a senior,...

Werde Teil von Clario, einem Unternehmen von Thermo Fisher Scientific, als **Senior Product Quality Engineer (f/m/d)** und arbeite bereichsübergreifend, um die Einhaltung des Quality Management Systems (QMS) von Clario aufzubauen, sicherzustellen und kontinuierlich zu verbessern. Du bringst deine Qualitäts- und Regulierungsexpertise entlang des gesamten...

Please note that the role requires travel of up to 50% of the time. Major Accountabilities Plan, lead, conduct, document, report and follow up on GCP/PV audits in accordance with Novartis procedures, applicable regulations, quality agreements, standards and guidance documents. Perform low-risk GCP/PV audits, such as investigator site audits, single-service...

Your roleWe are seeking a Director-level leader to head its Inspection & Trial Master File (TMF) Center of Excellence within the Global Development Operations (GDO) Clinical Quality Management (CQM) organization. This office-based (3 days on site per week) role is open across Germany, Switzerland and the US, and represents a high-impact senior strategic...

Senior CRAKey ResponsibilitiesAct as the primary contact for assigned clinical study sites in Germany.Conduct PSV, SIV, IMV, and COV visits, ensuring quality and compliance with the Monitoring Plan, SOPs, ICH-GCP, and applicable regulations.Support study start-up, including feasibility, site selection, and site initiation activities.Manage essential and...

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.General Description: The CRA executes clinical...