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Senior / Lead Quality Assurance Manager (m / f / d)

Senior / Lead Quality Assurance Manager (m / f / d)

Merz Aesthetics GmbHFrankfurt am Main, Hessen, Deutschland
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Senior / Lead Quality Assurance Manager (m / f / d) at Merz Aesthetics GmbH | softgarden.Senior / Lead Quality Assurance Manager (m / f / d). Altenhöferallee 5, 60438, Frankfurt am Main.Merz Aesthetics is a...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Quality Assurance Manager / Deputy Technical Director

Quality Assurance Manager / Deputy Technical Director

GrifolsFrankfurt am Main, Niederrad, DE
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
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Automated Testing Expert (m / w / d) - Quality Assurance, Ingenieur

Automated Testing Expert (m / w / d) - Quality Assurance, Ingenieur

LORENZ Life Sciences GroupFrankfurt am Main, DE
LORENZ ist ein führender Anbieter von Softwarelösungen für den digitalen Datenaustausch zwischen der pharmazeutischen Industrie und den Zulassungsbehörden.Wir sind unmittelbar d...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Consultant-Quality Assurance

Consultant-Quality Assurance

ElancoBad Homburg, DE
Vollzeit
At Elanco (NYSE : ELAN) – it all starts with animals!.As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm an...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
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Test Automation Engineer (all genders) - Quality Assurance, Ingenieur

Test Automation Engineer (all genders) - Quality Assurance, Ingenieur

beQualifiedFrankfurt am Main, DE
Du arbeitest eng mit dem Entwicklungsteam zusammen und trägst dazu bei, unsere Softwareprodukte auf das nächste Level zu heben. Uuml;BER beQualified GmbH.Bei der beQualified GmbH, ein...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
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Coordinator Quality Assurance (m / w / d)

Coordinator Quality Assurance (m / w / d)

Takko Fashion GmbHBad Homburg
Coordinator Quality Assurance (m / w / d).Aus Westfalen in die Welt - mit rund 18.Kolleginnen und Kollegen und fast 2.Stores in 17 Ländern sind wir einer der größten Fashion Discounter in Europa.Unsere...Mehr anzeigenZuletzt aktualisiert: vor 20 Stunden
Quality Assurance Assistenz (m / w / d)

Quality Assurance Assistenz (m / w / d)

BertrandtFrankfurt
Verantwortlich für die Lenkung, Verwaltung und Archivierung von GxP-relevanten Dokumenten .Unterstützung bei der Durchführung von GxP-Schulungsmaßnahmen. Mitarbeit bei der Erstellung von chemisch-ph...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Lead Operational Quality Assurance (m / w / d) New Assets

Lead Operational Quality Assurance (m / w / d) New Assets

Merz TherapeuticsFrankfurt am Main, Hessen, Deutschland
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Lead Operational Quality Assurance (m / w / d) New Assets.Lead Operational Quality Assurance (m / w / d) New Assets.Alfred-Wegener-Straße 2, 60438 Frankfurt am Main, Deutschland.Join our global quality o...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Quality Assurance Associate

Quality Assurance Associate

MarkenKelsterbach, Germany
Quality Assurance Associate (m / f / d).To mainly provide support to the CAPA System, Trainings and Vendor qualification process and records review. Main Duties and Responsibilities : .Maintain the cultur...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Coordinator Quality Assurance (m / w / d)

Coordinator Quality Assurance (m / w / d)

Takko FashionBad Homburg, DE
Coordinator Quality Assurance (m / w / d).Aus Westfalen in die Welt - mit rund 18.Kolleginnen und Kollegen und fast 2.Stores in 17 Ländern sind wir einer der größten Fashion Discounter in Europa.Unsere...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Quality assurance employee (m / f / d)

Quality assurance employee (m / f / d)

GULP – experts unitedFrankfurt am Main
From professionals for professionals : Our team of experts at Randstad professional solutions is currently looking for an experienced. Do you have a sense of responsibility and flexibility? An attrac...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Quality Assurance Manager (m / w / d) Pharma

Quality Assurance Manager (m / w / d) Pharma

FERCHAU GmbHFrankfurt
Menschen und Technologien verbinden.Den Perfect Match für unsere Kunden gestalten.Immer die richtigen Expert : innen für die jeweilige Herausforderung finden - das ist unser Anspruch bei FERCHAU und ...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
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Quality Engineer - Vertriebsanalytik (m / w / d) - Quality Assurance, Ingenieur

Quality Engineer - Vertriebsanalytik (m / w / d) - Quality Assurance, Ingenieur

Finanz InformatikFrankfurt am Main, DE
Mitarbeitern an 3 Standorten machen wir digitales Banking von heute leistungsfähig und entwickeln smarte Finanz-Services von morgen. Dabei bieten wir Dir ein breites Aufgabenspektrum, in dem Du...Mehr anzeigenZuletzt aktualisiert: vor 25 Tagen
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Quality Lead mfd Site Friedrichsdorf

Quality Lead mfd Site Friedrichsdorf

VALEO Telematik und AkustikHochtaunuskreis, Hesse, Germany
Valeo is a tech global company designing breakthrough solutions to reinvent the mobility.We are an automotive supplier partner to automakers and new mobility actors worldwide.Our vision Invent a gr...Mehr anzeigenZuletzt aktualisiert: vor 5 Tagen
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Praktikant / Werkstudent Audit & Assurance - Softwaretesting (m / d / w) - Quality Assurance, Ingenieur

Praktikant / Werkstudent Audit & Assurance - Softwaretesting (m / d / w) - Quality Assurance, Ingenieur

DeloitteFrankfurt am Main, DE
Ob im Business Audit & Assurance, Risk Advisory, Tax & Legal, Financial Advisory oder Consulting : Wir bei Deloitte unterstützen unsere weltweiten Mandanten dabei, sich kontinuierlich w...Mehr anzeigenZuletzt aktualisiert: vor 25 Tagen
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Agile Software Tester (w / m / d) - Quality Assurance, Ingenieur

Agile Software Tester (w / m / d) - Quality Assurance, Ingenieur

Sogeti – Part of CapgeminiFrankfurt am Main, DE
Als Consulting-Unternehmen mit echter Hands-On Mentalität bieten wir Dir neben spannenden Projekten in coolen Branchen ständige Weiterentwicklung – fachlich und persönlich.Dabe...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Field Quality Assurance Specialist (m / w / d)

Field Quality Assurance Specialist (m / w / d)

Amazon Deutschland S38 Transport GmbH - L98Frankfurt, DE
Über unsOperations is the heart and soul of everything Amazon does.As member of the ACES (Amazon Customer Excellence Systems) and Quality team, you will solve complex challenges and contribute to t...Mehr anzeigenZuletzt aktualisiert: vor 4 Tagen
Healthcare Quality Assurance Internship (f / m / d)

Healthcare Quality Assurance Internship (f / m / d)

Procter & GambleSchwalbach Am Taunus
Vollzeit
Are you looking to apply your knowledge to practice? Are you eager to lead exciting projects and have a meaningful impact with your ideas? You relish a culture in which your development is key and ...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
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Quality Assurance Manager (m / w / d) Pharma

Quality Assurance Manager (m / w / d) Pharma

FERCHAU – Connecting People and TechnologiesFrankfurt am Main, Deutschland
Menschen und Technologien verbinden.Den Perfect Match für unsere Kunden gestalten.Immer die richtigen Expert : innen für die jeweilige Herausforderung finden - das ist unser Anspruch bei FERCHAU und ...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Praktikum Quality Assurance (m / w / d)

Praktikum Quality Assurance (m / w / d)

cosnova GmbHSulzbach (Taunus)
Du unterstützt unsere QA Manager bei deren alltäglichen Tätigkeiten im Bereich Qualitätssicherung und Kosmetikrecht mit besonderem Fokus auf Verwaltung von Inhaltsstoff- und Rezepturdatenbanken Unt...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
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Senior / Lead Quality Assurance Manager (m / f / d)

Senior / Lead Quality Assurance Manager (m / f / d)

Merz Aesthetics GmbHFrankfurt am Main, Hessen, Deutschland
Vor 30+ Tagen
Anstellungsart
  • Quick Apply
Stellenbeschreibung

Senior / Lead Quality Assurance Manager (m / f / d) at Merz Aesthetics GmbH | softgarden

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Senior / Lead Quality Assurance Manager (m / f / d)

Full Time

Hybrid

Altenhöferallee 5, 60438, Frankfurt am Main

With Professional Experience

1 / 2 / 25

Merz Aesthetics is an international company in the field of aesthetic medicine. Our broad product portfolio is synonymous with top quality in each of their categories and is highly regarded by healthcare professionals worldwide. As Merz Aesthetics, we are part of the Merz Group with our EMEA headquarters located in Frankfurt am Main, Germany. Our global head office is located in Raleigh, North Carolina, USA. Every day, more than 2,500 employees in 26 countries are committed to restoring and maintaining the skin's beauty. Would you like to become part of our success story? Then join Merz Aesthetics!

The following responsibilities are awaiting you :

  • You plan and perform various Clinical medical devices & medicinal products project audits against GxP and local regulatory requirements.
  • You create audit plans for the studies, based on risk assessments / analyses, as well as plan and perform internal process and vendor audits.
  • You lead the evaluation and management of clinical site-specific escalations related to persistent or serious misconduct.
  • You collaborate in the further development and maintenance of the Quality Management System, e.g., document management, CAPA, deviation, and SOP System.
  • You assist in the development of Company Standard Operating Procedures and collaborate on quality metrics for reporting to leadership.
  • You act as a QA Business Partner for the Clinical Operation team to overview and support relevant ClinOps sub-divisions on CAPAs management.
  • You provide independent consultation with a focus on clinical activities and for quality-related and GCP-related inquiries for Clinical activities in Ax R&D.
  • You support the qualification process of suppliers relevant for clinical development.
  • You plan and perform various clinical vendors audits against GxP and local regulatory requirements.
  • You contribute to training for selected functional groups related to Good Clinical Practice, Good Clinical Laboratory Practice, Good Pharmacovigilance Practice (pre-marketing related), and clinical trials regulations.
  • You host the local and international Notified Body and authorities’ inspection / External Audits.
  • You manage CAPA of the RA inspections / External Audits as well as support inspection readiness / regulatory compliance status at R&D.

What we expect from you :

  • You ideally hold a Master’s Degree in natural science, pharmacy, or medicine.
  • You have 10 years of professional experience in the field of clinical research oversight and / or management.
  • You have 5 years of professional experience as a QA Auditor and executing a QA Manager role in the pharmaceutical / medical device industry.
  • You ideally have prior experience developing risk-based quality management programs across clinical development.
  • You have first experience working and communicating within cross-functional and international teams.
  • You understand the overall clinical trial management process, including the protocol and other clinical trial-related plans and documents.
  • You have critical thinking and analytical skills to understand and analyze complex data and provide insight into risk reports, trends, and outliers in data.
  • You have comprehensive knowledge of the regulations and standards for conducting clinical trials in the field of medical devices or medicinal products.
  • You possess comprehensive knowledge in the execution of audits in the "GCP" area (medical device products : ISO 14155 or pharmaceutical : ICH-GCP "E6").
  • You manage and facilitate audits / inspections.
  • You understand the ICH and regulatory environment.
  • You are an analytical thinker with strong communication skills and the ability to work independently.
  • You are highly motivated and willing to learn new areas of work, as well as like to travel nationally and internationally for audits (average 20% of travel).
  • You demonstrate a high level of commitment, discretion, sense of responsibility, reliability, accuracy, and confident appearance.
  • You are business fluent in English, additional languages skills in German are preferable.
  • You possess strong Microsoft Office skills.
  • What you can expect from us :

    Putting people first : You can expect to find an open work culture with flat hierarchies and short decision-making paths at Merz Aesthetics. You will collaborate with colleagues from all around the globe. And if life takes an unexpected turn and you need help or advice, then you can always rely on our different internal and external support systems.

    Family and work : Our employees should be able to reconcile their family and work commitments. That’s why you’ll find, for example, company day care centers at our locations. In the EMEA region, we have been awarded the “Top Employer” and “Great Place to Work” certifications for our outstanding HR policies and work culture.

    Work-life harmony : Our time is precious; our daily routines individual. To help you reconcile work and leisure time with their conflicting demands, we have adopted contemporary flexible working time models. We offer you flex-working time and mobile working. Our employees also benefit from generous arrangements for annual leave.

    Ongoing training : Your personal and professional development is the key to success for us. To foster this, we conduct regular development discussions and facilitate a wide range of management and specialist training courses, soft skills courses, e-learning courses, language courses and coaching sessions.

    Find out more about our benefits at https : / / careers.merz-aesthetics.com .

    We look forward to your application!

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