Senior Quality Assurance Manager CMO

vor 1 Woche


Wien, Wien, Österreich Valneva Vollzeit

We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs.

We have leveraged our expertise and capabilities both to commercialize three vaccines, including the world's first and only chikungunya vaccine, and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease and Zika.

With operations in Austria, Canada, France, Sweden, the United Kingdom, and the , we are committed to making a positive impact on global public health.

Together, we are a global Company which is open to people of all backgrounds. Our diverse and inclusive workforce makes Valneva a great place to work.

Responsibilities

Work as primary Quality Assurance point of contact to internal and external partners (Contract Manufacturing Organizations (CMOs), other Valneva sites) Lead/support projects in the life-cycle of Valneva's products at external partners from a QA perspective Perform review, QA approval and administration of external documents ( Reports, Deviations, Changes) Take over responsibilities for certain Valneva's Quality Systems Responsible for the maintenance and continuous improvement of QM-Systems related to the oversight of external partners/CMOs ( handling of external non-conformance records, documents and Change Controls) Interact with QP's as well as other internal stakeholders regarding Quality Oversight of CMO operations for marketed products Tracking and reporting of key performance indicators Participate in compilation of Product Quality Reviews Contribute to the continuous improvement of the quality assurance management system for all aspects of the activities of Valneva Austria, compliant with coordinated policies for Quality Assurance which are consistent with current GMDPs, relevant Health and Safety Regulations and other relevant current legislation Actively support Quality Assurance activities related to administration & training of Quality Systems

Requirements

HTL, Bachelor or Master Degree or equivalent in a relevant field (, Biotechnology, Bioengineering, Chemistry, Molecular Biology, Biology) At least 3-5 years of experience within QA/ GMP regulated environment, preferably at a manufacturing site in Biotechnology / Pharmaceutical Industry Good knowledge of GMP regulatory framework and regulatory bodies Excellent communication skills and able to work cross-functional, independently but also in a team Experience with CMO's Skills in transferring knowledge (trainings), presentation skills for miscellaneous customers (experienced, non-experienced audience) Ability to organize and schedule work within a busy office with experience of writing and working to SOP documentation Proactive and solution-oriented in a fast-changing environment Detail oriented, quick grasp of understanding Excellent command of German & English (spoken and written) and excellent IT skills

Benefits

Open, appreciative company culture with innovative spirit and attractive assignments International surrounding with flat hierarchies Good team spirit in a strong and highly motivated team Wide range of benefits like flexitime, compensation days, performance-related bonus, lunch vouchers, child care center ("Kindergarten"), company events, myClubs, LinkedIn Learning etc.

Due to legal reasons we are obliged to disclose the minimum salary for this position, which is € ,- gross per year based on full-time employment. However our salaries are market oriented and in line with your qualifications and experience.



  • Wien, Wien, Österreich Valneva Vollzeit

    or only-in-class vaccine solutions.We have a strong track record, having advanced multiple vaccines from early R&D to approvals, and currently market three proprietary travel vaccines, including the world's first and only chikungunya vaccine, as well as certain third-party vaccines.Responsibilities Work as primary Quality Assurance point of contact to...


  • Wien, Wien, Österreich Eblinger & Partner Vollzeit

    Unser Kunde ist ein erfolgreiches **Familienunternehmen**, das **forschend tätig** ist und seine Produkte weltweit **marktführend** vertreibt.Für die Niederlassung in **Wien** suchen wir eine*n Regulatory & Quality Assurance Manager*in. Dabei wenden wir uns an engagierte Persönlichkeiten mit ausgeprägtem wissenschaftlichem Interesse und Freude am...


  • Wien, Wien, Österreich Valneva Austria GmbH Vollzeit

    Description:- or only-in-class vaccine solutions.We have a strong track record, having advanced multiple vaccines from early R&D to approvals, and currently market three proprietary travel vaccines, including the world's first and only chikungunya vaccine, as well as certain third-party vaccines.Responsibilities Establish, maintain and continually improve...


  • Wien, Wien, Österreich Valneva Vollzeit

    or only-in-class vaccine solutions.We have a strong track record, having advanced multiple vaccines from early R&D to approvals, and currently market three proprietary travel vaccines, including the world's first and only chikungunya vaccine, as well as certain third-party vaccines.Responsibilities Establish, maintain and continually improve the quality...

  • European Quality

    vor 2 Monaten


    Wien, Wien, Österreich Page Executive Vollzeit

    About Our Client Our client is a well-established Bio-tech company with significant growth potential. The company cultivates a work environment that promotes proactive initiative and supports rapid decision-making through a flat organisational structure. Job Description Lead the vendor and CMO management processes with an emphasis on compliance and...

  • European Quality

    vor 1 Woche


    Wien, Wien, Österreich Page Executive Vollzeit

    About Our Client Our client is a well-established Bio-tech company with significant growth potential. The company cultivates a work environment that promotes proactive initiative and supports rapid decision-making through a flat organisational structure. Job Description Lead the vendor and CMO management processes with an emphasis on compliance and...

  • European Quality

    vor 4 Wochen


    Wien, Wien, Österreich Page Executive Vollzeit

    About Our Client Our client is a well-established Bio-tech company with significant growth potential. The company cultivates a work environment that promotes proactive initiative and supports rapid decision-making through a flat organisational structure. Job Description Lead the vendor and CMO management processes with an emphasis on compliance and...


  • Wien, Wien, Österreich Valneva Vollzeit

    We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. We take a highly specialized and targeted approach, applying our deep expertise across multiple vaccine modalities, focused on providing either first-, best- or only-in-class vaccine solutions.We...


  • Wien, Wien, Österreich Takeda Pharmaceutical Vollzeit

    In dieser abwechslungsreichen Rolle arbeiten Sie gemeinsam mit Ihrem Quality Assurance Team eng mit zahlreichen Abteilungen von BioLife und Manufacturing sowohl in Europa als auch in den USA zusammen. Als Partner auf Augenhöhe sorgen Sie mit Fingerspitzengefühl dafür, dass alle relevanten Qualitätsziele und -vorgaben umgesetzt werden und alle Beteiligten...


  • Wien, Wien, Österreich UBIMET Austria GmbH Vollzeit

    UBIMET has its headquarters in Vienna, Austria and ranks among the leading weather service providers worldwide while being the only fully independent service provider in Europe. International experts in the fields of meteorology, physics, biology and geography issue customized, individual and precise weather forecasts for several million private and...


  • Wien, Wien, Österreich Dedalus HealthCare GmbH Vollzeit

    Dedalus produces, distributes, implements and maintains complex, technologically advanced and innovative IT solutions for hospitals, rehabilitation clinics, psychiatric clinics and diagnostic facilities such as radiology and cardiology. These IT solutions support all essential processes of administration, documentation, workflow control and audit-proof...


  • Wien, Wien, Österreich Dedalus Vollzeit

    Do you want a job with a purpose? And do you want to make healthcare safer, better and more reliable? Join our Team We are Dedalus HealthCare, a major player of healthcare software solutions, located in Vienna. We are looking for passion and highly motivated individuals that desire to be part of something big. With us, each individual employee...


  • Wien, Wien, Österreich St. Anna Kinderkrebsforschung Vollzeit

    **Ort**:**Forschungsgruppe**:**Arbeitszeit**:- Vienna Qualitätsmanagement Part-time / full-time- Ihr Herz schlägt für Qualitätsmanagement?- Sie arbeiten gerne im Team und sind auf der Suche nach einer Arbeit "mit Sinn"?- Dann sind Sie bei uns genau richtigZur Verstärkung unserer Abteilung Qualitätsmanagement / Qualitätssicherung suchen wir zum...


  • Wien, Wien, Österreich REWE International IT Vollzeit

    Company DescriptionAs IT of the REWE Group Austria, we work together with our more than 600 employees to develop innovative IT products and services for all our corporate divisions in Austria and abroad, setting the tone for modern trade.As Quality Assurance Expert you will be part of the Application Architecture quality assurance team. You will be...


  • Wien, Wien, Österreich MSD Vollzeit

    **Job Description**:Das erklärte Ziel unseres Unternehmensbereichs Produktion & Lieferung ist es, als weltweit zuverlässigster Hersteller und Lieferant von Biopharmazeutika zu agieren. Unsere Produktionsstätten bilden gemeinsam mit unseren externen Auftragnehmern, Zulieferern und Partnern ein eng verflochtenes globales Produktionsnetzwerk, das es sich zur...


  • Wien, Wien, Österreich Völker Personal Vollzeit

    Für die Herstellung und für den Vertrieb von Tierpharmazeutika sowie für den Großhandel mit chemischen Erzeugnissen beschäftigt sich unser Kunde in 1210 Wien.Eingestellt wird ab sofort für 25-30 Wochenstunden ein Werkstudent zur administrativen Unterstützung (m/w/d).Führerschein B und eigenes KFZ sind zur Anreise an den Arbeitsort von Vorteil, jedoch...


  • Wien, Wien, Österreich JOBS Experts Industrieservice GmbH Vollzeit

    JOBS Experts - die Profis, wenn es um Ihre berufliche Zukunft geht.Wir suchen für unseren Kunden, einer der weltweit erfolgreichsten Pharmakonzerne für den Standort in 1210 Wien eine/-n Quality Assurance Specialist (m/w/d).Geboten wird: * Spannendes und herausforderndes Aufgabengebiet mit Selbstverantwortung. * Teamorientiertes Umfeld. * Vollzeitstelle /...


  • Wien, Wien, Österreich JOBS Experts Industrieservice GmbH Vollzeit

    JOBS Experts - die Profis, wenn es um Ihre berufliche Zukunft geht.Wir suchen für unseren Kunden, einer der weltweit erfolgreichsten Pharmakonzerne für den Standort in 1210 Wien eine/-n Quality Assurance Specialist (m/w/d).Geboten wird:Spannendes und herausforderndes Aufgabengebiet mit Selbstverantwortung.Teamorientiertes Umfeld.Vollzeitstelle / 38 Stunden...


  • Wien, Wien, Österreich BAXTER Vollzeit

    This is where you save and sustain livesAt Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.Baxter's products and therapies are found in almost...


  • Wien, Wien, Österreich Galderma Vollzeit

    With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that spans the full spectrum of the fast-growing dermatology market through Injectable...