Business Product Owner – CellChain Quality, Manufacturing and Labelling
PharmaRegulatory AffairsQuality Assurancecroinformsap
Job description
Salary Range: 195.700,00 zł - 363.400,00 zł Job Description Summary #LI-Hybrid Location: Warsaw, Poland Relocation Support: This role is based in Warsaw, Poland. Novartis is unable to offer relocation support: please only apply if accessible. Take on a key role supporting personalised CAR-T products and helping ensure continuity of patient supply. You will be responsible for global GxP back-end capabilities supporting quality, manufacturing, batch release, labelling and Chain of Identity, including product governance, change approvals and compliant releases across the US and international markets. At the same time, you will lead the NTO CellChain team, ensuring continuity and supporting reliable patient supply, while working in accordance with legislation, internal requirements, good practices and business objectives. Job Description Key responsibilities: Resolve plant, batch-release, labelling and data-flow issues within defined Quality boundaries and manage relevant escalations. Maintain business rationale behind existing controls and configurations, supporting CellChain continuity and knowledge retention. Identify improvement opportunities across quality, leukapheresis, batch disposition and labelling processes with key business stakeholders. Drive standardisation and reduce local variations to protect the integrity of the global product design. Support effective integration between CellChain products and regional solutions, contributing to overall product integrity. Drive and align key design decisions with business process owners and Quality stakeholders. Partner with Digital, Data and Information Technology on product design, technical integration and ongoing operational support. Ensure compliance with Good Manufacturing Practice, GxP, computerised system validation and applicable regulatory requirements. Drive continuous improvement of CellChain capabilities supporting personalised CAR-T products and contribute to the overall roadmap. Essential requirements: Minimum 5 years of experience successfully working in the pharmaceutical industry, with at least 2 years in a function with QA, labelling or manufacturing operations focus, or equivalent experience in a related field. Knowledge and use of modern digital, technological, and AI enabled tools and systems. Proficiency in Slovene and English language, where required by the work process. University education in natural sciences, Engineering discipline, Quality, Manufacturing or other relevant field. Rewards At Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen. Expected Annual Base Salary Range for role: 195.700,00 - 363.400,00 PLN The base salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically. In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters. The rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs. In addition, we provide flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave. Pay equity is a fundamental principle of our employment policy and reflects our commitment to create a diverse, equitable and inclusive environment that treats all employees with dignity and respect, as outlined in our Code of Ethics. Read our brochure to learn more about our global total rewards offering: https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf Note: Benefits and compensation may vary by country and are subject to local legal requirements, including provisions of collective bargaining agreements where applicable. A full overview of your compensation package, including any relevant collective bargaining agreement details applicable to your role based on your employment location and Novartis employer entity, will be communicated separately to you during the application process. Commitment to Diversity and Inclusion Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Skills Desired Data Analytics, Emotional Resilience, Integrated Business Planning (IBP), Inventory Management, Leadership, Master Data, Operational Excellence, Project Management, Risk Management, SAP Enterprise Resource Planning (ERP), Stakeholder Management, Supply Chain Planning (SCP), Transportation And Logistics
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