Product Quality Lead
hace 3 semanas
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 DescriptionMajor 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 QBTA 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 BTA 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 Requirements:Work Experience: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.
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Product Quality Lead
hace 3 semanas
Barcelona, España Healthcare Businesswomen’S Association A tiempo completoJob Description Summary 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. Job Description...
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Product Quality Lead
hace 3 semanas
Barcelona, España Healthcare Businesswomen’S Association A tiempo completoJob Description Summary 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.Job Description...
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Product Quality Lead
hace 3 semanas
Barcelona, España Healthcare Businesswomen’S Association A tiempo completoJob 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...
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Product Quality Lead
hace 3 semanas
Barcelona, España Healthcare Businesswomen’S Association A tiempo completoJob Description Summary 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. Job Description...
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Product Quality Lead
hace 2 semanas
Barcelona, España Novartis A tiempo completo.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.About the RoleMajor...
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Product Quality Lead
hace 3 semanas
Barcelona, 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 Role Major...
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Product Quality Lead
hace 3 semanas
Barcelona, España Healthcare Businesswomen’s Association A tiempo completoJob Description Summary 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. Job Description...
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Product Quality Lead
hace 3 semanas
Barcelona, España Healthcare Businesswomen’s Association A tiempo completoJob 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...
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Product Quality Lead
hace 3 semanas
Barcelona, España Novartis Farmacéutica A tiempo completoThe 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:...
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Product Quality Lead
hace 2 semanas
Barcelona, España Novartis Farmacéutica A tiempo completoThe 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...
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Product Quality Lead
hace 3 semanas
Barcelona, España Novartis A tiempo completo**Summary**: 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...
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Product Quality Lead
hace 3 semanas
Barcelona, España Novartis Farmacéutica A tiempo completoThe 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...
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Product Quality Lead
hace 3 semanas
Barcelona, España Novartis Farmacéutica A tiempo completoThe 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 Role Major accountabilities: ...
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Product Quality Lead |
hace 1 día
Barcelona, España Ares Consultores A tiempo completoSummaryThe 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 Role Major...
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Product Quality Lead |
hace 1 día
Barcelona, España Ares Consultores A tiempo completoSummary 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 Role Major...
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Product Quality Lead |
hace 1 día
Barcelona, España ARES CONSULTORES A tiempo completoSummary 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 Role Major...
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Product Quality Lead |
hace 3 días
Barcelona, España ARES CONSULTORES A tiempo completoSummaryThe 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...
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Inicio Inmediato: Product Quality Lead
hace 3 semanas
Barcelona, España Healthcare Businesswomen’S Association A tiempo completoJob 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...
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Product Quality Lead
hace 2 semanas
Barcelona, Barcelona, España Novartis Farmacéutica A tiempo completoAbout the RoleThe Product Quality Lead plays a pivotal role in ensuring the holistic quality stewardship of assigned Novartis biologics (NBE) and ATMP across multiple sites, from late phase development to discontinuation.Key Accountabilities:Responsible for end-to-end quality stewardship of assigned Novartis biologics product(s) from late phase development...
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Biologics Quality Lead
hace 2 semanas
Barcelona, Barcelona, España Healthcare Businesswomen's Association A tiempo completoJob Description: Biologics Quality LeadThe Healthcare Businesswomen's Association is seeking a highly skilled Biologics Quality Lead to drive the end-to-end product quality strategy for assigned Novartis biologics. As a key member of the organization, you will be responsible for ensuring the quality strategy is aligned with global regulatory requirements and...
