Product Quality Lead

hace 2 semanas


España Novartis Farmacéutica A tiempo completo

The Product Quality Lead is responsible for the holistic product quality stewardship of assigned Novartis biologics (NBE) and ATMP (Advance Therapy Medicinal Products) across multiple sites (or platforms, DS and DP sites, including CMOs) throughout the product lifecycle, from late phase development to discontinuation.About the RoleMajor accountabilities:Accountable for end-to-end quality stewardship (DS and DP) of assigned Novartis biologics product(s) (NBE’s and biosimilars) from late phase development to discontinuation.Accountable for the end-to-end product quality strategy (DS and DP) across the global network and drive continual improvement through product and process lifecycle management, represent QBT&A in cross-functional project life cycle team.Provide expert quality guidance, technical support and quality leadership for implementation of quality guidelines, regulations, standards, processes, and strategy for assigned product(s) throughout the product and process lifecycle.Maintain global Quality oversight, oversee global regulatory filing activities including product registration and variation management, of assigned Novartis biologics product(s) (NBE’s and biosimilars).Act as global quality lead in product related Q escalations, recalls and BPDR handling for product specific quality and compliance challenges. Provide clear direction and drive efficient decision making for global Quality issues related to assigned products.Involved in major product relevant investigations, in particular multi-sites deviations and recurring deviations, by leading/supporting global investigations/Task Force at the sites.Support global site readiness for product pre-approval inspections across the BT&A platform/network.Bridge between clinical, development and technical operation teams and engages at multiple interface(s) between the organizations to functionally lead and drive robust execution of the defined Product related Quality Program.Actively drive platform wide Q strategy harmonization and promote product Quality as competitive advantage.Minimum Qualifications:5+ years of experience in an operational GxP area in a Manufacturing/Development or Quality.Solid knowledge in biology/chemistry, pharmacy and biotechnology, medical devices/combination products.Thorough knowledge and expertise in cGMP and applicable guidelines.Sound scientific, technical and regulatory knowledge, ideally in Biotechnology; expertise in validation (process and cleaning) a plus.Excellent and proven ability to analyze and evaluate cGMP compliance.Proven ability to influence people and communicate in a process-oriented organization.Fluent English, written and spoken. Any additional language is a plus.Why Novartis? Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us
#J-18808-Ljbffr


  • Product Quality Lead

    hace 2 semanas


    España Healthcare Businesswomen’s Association A tiempo completo

    Job Description SummaryThe Product Quality Lead is responsible for the holistic product quality stewardship of assigned Novartis biologics (NBE) and ATMP (Advance Therapy Medicinal Products) across multiple sites (or platforms, DS and DP sites, including CMOs) throughout the product lifecycle, from late phase development to discontinuation.Job...

  • Quality Assurance Lead

    hace 2 meses


    España Roche A tiempo completo

    The Position Quality Assurance Lead Throughout our 125-year history, Roche has grown into one of the world’s largest biotech companies and a global supplier of transformative innovative solutions across major disease areas. At Roche, we believe every employee makes a difference. We are passionate about transforming patients’ lives. We are confident in...


  • España Product School A tiempo completo

    Lead Customer Success Manager, Enterprise We’re on a mission at Product School… … to empower people to build better products! As the global leader in Product Management certifications, we train Product Managers at all career stages and entire Product teams within organizations. In addition to offering the industry’s most recognized Product Management...


  • España Capgemini Engineering A tiempo completo

    En Capgemini Engineering estamos creciendo, y desde nuestra industria de Mecánica queremos incroporar perfiles como tú. Pensamos en alguien con experiência como Product Quality Engineer para trabajar en uno de nuestros proyectos del sector automoción que está ubicado en Viladecavalls (Barcelona). **Funciones y proyecto**: - Ensure, together with the...


  • España Capgemini Engineering A tiempo completo

    En Capgemini Engineering estamos creciendo, y desde nuestra industria de Mecánica queremos incroporar perfiles como tú. Pensamos en alguien con experiência como Product Quality Engineer para trabajar en uno de nuestros proyectos del sector automoción que está ubicado en Viladecavalls (Barcelona). **Funciones y proyecto**: - Ensure, together with the...


  • España Product School A tiempo completo

    Spain **Lead, Paid Media Manager**: **We’re on a mission at Product School** to empower people to build better products! As the global leader in Product Management certifications, we train Product Managers at all career stages and entire Product teams within organizations. Delivered live by globally recognized instructors, our certifications empower...


  • España Nippon Gases UK & Ireland A tiempo completo

    Noxtec Development, established in 2016, part of Nippon Gases, develops, manufactures and distributes high technology medical devices with an important added value for the users and patients globally.Over the years, Noxtec has developed extensive know-how in inhaled nitric oxide therapies, starting in neonatal intensive care units and then focusing on...


  • España eDreams ODIGEO A tiempo completo

    As you contemplate your future you might be asking yourself what's the next step? Start your journey with us. We are looking for a CX Quality Assurance Lead to join our Customer Service team based in Barcelona. Together with the team, you will define, develop, and maintain a quality program and ensure that the various global delivery centres and teams are...


  • España Monogram A tiempo completo

    About us Bakken & Bæck is a technology-driven design studio working out of Oslo, Amsterdam, Bonn, Barcelona and London. Building digital products, brands, and businesses, we help ambitious companies identify, explore and respond to new opportunities. From defining the future home with IKEA to building decentralised platforms with Coinbase; we are in the...


  • España Celestica Inc. A tiempo completo

    Product Design Technical LeadDate: Oct 23, 2024Job Title: Staff Engineer, Systems/Applications DesignFunctional Area: Engineering (ENG)Career Stream: Design Engineering Systems/Applications (DSA)Role: Staff Engineer (SEN)Job Code: SEN-ENG-DSAJob Band: 10Direct/Indirect Indicator: IndirectSummaryCelestica is a world leader in the electronic manufacturing...


  • España Joko A tiempo completo

    ️Who we areWe help consumers shop smarter. Our ambition is to revolutionize the way people shop, empowering them to find what they need, make informed purchasing decisions, and save money.Joko is a tech company founded in Paris. Our team of over 50 talents is international and spread across offices in Paris, Barcelona and New York, or working remotely.As a...


  • España Celestica A tiempo completo

    Req ID: 123405 Remote Position: Hybrid Region: Europe Country: Spain State/Province: La Pobla De Vallbona City: Valencia General Overview Job Title: Staff Engineer, Systems/Applications Design Functional Area: Engineering (ENG) Career Stream: Design Engineering Systems/Applications (DSA) Role: Staff Engineer (SEN) Job Code: SEN-ENG-DSA Job Band: 10...


  • España buscojobs España A tiempo completo

    With a strong track record and presence in various cities, the company specializes in gastronomic services that stand out for their exceptional quality, authenticity, and distinctive flavors, backed by exclusive products. Over the years, they have solidified their reputation by fostering strong relationships with clients and strategic partners.They are...

  • Training & Quality Lead

    hace 2 semanas


    España Lynk & Co A tiempo completo

    At Lynk & Co, we’re not just launching a new mobility brand; we’re transforming how people think about transportation. We invite you to be part of this journey as we redefine the experience of buying, owning, and using a car, with customer engagement at the heart of our success.We are seeking a Training & Quality Lead to join our dynamic Customer...


  • España PERFUMES LOEWE A tiempo completo

    MISSIONAre you passionate about the luxury and beauty sector? Do you want to discover this world through our Production department? This is your opportunity! This internship will help you develop your career and acquire practical experience through participation, collaboration, and support in different functions and tasks.ORGANISATIONAL STRUCTURE /...


  • España LanguageWire Ltd A tiempo completo

    LanguageWire is seeking an experienced Machine Learning Team Lead with expertise in product and API development to spearhead our AI/NLP initiatives.The role you’ll playIn this critical role, the successful candidate will leverage advanced AI and NLP technologies to enhance our product offerings and expand our capabilities, both for internal and external...


  • España Aplo A tiempo completo

    Joko's Product team groups the passionate individuals behind our users' delight! From brainstorming to development to launch, the Product team's main mission is to turn ideas into reality by working hand-in-hand with the Engineering and Business teams.Your scopeAs Lead Product Manager, you will have the key role of coordinating multiple Product squads while...

  • Quality Engineer

    hace 2 meses


    España Knowledge Development for Plastic Optical Fiber A tiempo completo

    Work Profile The Quality Engineer is responsible for leading and maintaining all required automotive industry quality compliance procedures. Additionally, the Quality Engineer acts as a liaison with suppliers and customers relating to quality requests and testing processes. Responsibilities of the Quality Engineer include - Assist quality manager to...


  • España eDreams ODIGEO A tiempo completo

    As you contemplate your future, you might be asking yourself, what’s the next step? Start your journey with us! We are looking for a CX Quality Assurance Lead to join our Customer Service team based in Barcelona. Together with the team you will define, develop and maintain a quality program, and ensure that the various global delivery centres and teams are...


  • España buscojobs España A tiempo completo

    Joko's Product team groups the passionate individuals behind our users' delight! From brainstorming to development to launch, the Product team's main mission is to turn ideas into reality by working hand-in-hand with the Engineering and Business teams.Your scopeAs Lead Product Manager, you will have the key role of coordinating multiple Product squads while...