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366526BR Job ID: 366526BR Job Description: QA Team Lead ESO Large Molecules Warsaw, Poland 766 million patients were reached with Novartis medicines. We aspire to get Novartis medicines in the hands and homes of patients by delivering a Triple Win: A Win for Patients; A Win for Healthcare Systems, and A Win for Novartis. QA Team Lead ESO Large Molecules ensures all aspects of manufacturing, testing, release and distribution for key biologics and/or sterile pharmaceutical products at strategic external supplier sites comply with international standards of current Good Manufacturing Practice (cGMP), regulatory requirements, the Novartis Group Quality Manual, and the applicable Quality Agreements. Your key responsibilities: Your responsibilities include, but are not limited to: • Provides direction and formulates strategies to maintain and improve the external supplier quality oversight. Establishes and maintains quality relationship with strategic suppliers. • Acts as Single Point of Contact / SPOC for all quality related activities at assigned external suppliers. Provides the quality presence and input to technical meetings with the external suppliers and establishes good working relationships. External supplier quality related activities are further described in the subsequent paragraphs. Conducts all necessary trainings in due course to be suitably qualified to perform the assigned duties. • Supplier qualification: Ensures a valid Quality Agreement in line with the requirements of the Novartis global template is in place and continuously amended to the business needs. Ensures current external supplier quality risk assessments are in place and appropriate actions are taken to mitigate potential risks. Ensures site readiness for regulatory inspections and quality audits and supports during such events. • Routine monitoring: Assesses quality trends and drives continuous improvement including stability reports and annual product quality reviews. Critically assesses the performance of the product and process performed at the external supplier. Escalate any issues or instances of instability as necessary. Implements and monitors Key Performance Indicators (KPI) and ensures that all parts of ESO are working in a consistent manner against harmonized expectations. Initiates corrective actions when necessary and performs follow-up on resulting measures. • Incident management: Manages all quality issues (complaints, deviations, OOX). Ensures investigations are correctly executed and all required actions are taken appropriately and in a timely fashion. Escalates and represents cases within the Novartis quality escalation process. • Change controls: Ensures that change requests, either from the external supplier or from Novartis, are managed appropriately from receipt, through to the implementation and closure. • Manufacturing process and analytical methods transfers: Ensures QA Oversight during commercial product transfers. Assesses validation readiness. Ensures knowledge transfer for stable commercial manufacturing operations. Supports the establishment of continuous process verification programs. \n\n\n\n{#400,300#}#/video#] Position Title: QA Team Lead ESO Large Molecules Minimum requirements: What you’ll bring to the role: Essential: • Min 8 years of experience in in the pharmaceutical industry. Min 5 years of experience in the manufacturing of sterile pharmaceuticals. Expert knowledge in aseptic/sterile pharmaceutical processes and manufacturing of biologics. • Min 5 years of experience in operational quality assurance. Expert knowledge of cGMP requirements for major regulated markets (EU, US). Advanced experience with FDA, EMEA and other Health Authorities. Expert in risk management. Advanced understanding of project management. • leadership experience • Expert in communication and advanced negations skills. Advanced decision-making skills. Why Novartis? 766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis! Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network Job Type: Full Time Country: Poland Work Location: Warszawa Functional Area: Commercial & General Management Division: Innovative Medicines International & Chief Commercial Office Business Unit: Region Europe IMI Employment Type: Regular Company/Legal Entity: Novartis Poland Sp. Z o.o Commitment to Diversity & Inclusion:: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Shift Work: No Early Talent: No