Job Opening for Quality Manager in Novartis (Fort Worth, TX)

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Job Category : Management
Company Name: Novartis
Position Name: Quality Manager
Location : Fort Worth, TX
Job Description : 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! Manage projects and processes to support departmental portfolio, projects and objectives according to agreed timelines and standards. Ensure compliance with cGMP is maintained in TRD. Major Accountabilities (Describe the main results of the job to be achieved ) Support a discipline and/or provide a service individually or within a team of associates. May provide functional expertise to Line Unit and other QA Units in area of responsibility. Write, review, decide on approval and/or release of GMP-relevant deliverables and/or related tools as per area of responsibility in order to ensure compliance. Manage project related activities (e.g. TRD product portfolio, development of new tools, processes, Quality initiatives, Quality Manual implementation, Quality Plans, Quality Risk Assessments, training activities, qualification and facility upgrade activities, IT validation projects) as per area of responsibility. Support project management functions as a project team member. Provide support to TRD line functions in GMP related topics as per area of responsibility. Comply with internal and external guidelines regarding quality and safety (Quality Manual, regulatory cGMP guidelines, Health Authority guidance, SOPs etc.). Additional specific tasks Area of responsibility Manage quality assurance activities and responsibilities in the TRD USFW Pilot Facility, TRD ARD and TRD USFW CSM unit, as defined by TRD Quality Manual, global and local SOP and applicable regulations. Maintain quality systems for TRD USFW Pilot Facility, TRD ARD and TRD USFW CSM to assure all pharmaceutical manufacturing procedures meet applicable Novartis standards and US, EU cGMPs. Assure continuous quality improvement and regulatory compliance by monitoring/reporting key quality indicators, conducting internal compliance audits and reporting to management. Maintain up-to-date knowledge of aseptic processing requirements, cGMP and Novartis company priorities. Specifics Has the authority for approval or rejection of all components, raw material, excipients, packaging materials, drug substance, drug product intermediates, bulk drug products, combination products, medical device components, clinical finished goods for clinical and toxicological and/or animal studies. SME for aseptic process and medical devices. Has the approval and release authorities under Quality Project Manager (QPM), QPM 3rd Party QA Management, QPM Operations, QPM Qualification, and QPM CSM defined by FRM-7038019. Quality Assurance on the Shop Floor responsible defined by SOP-7045332. Manage quality touchpoint meetings defined by WP-7007576. Key Performance Indicators –KPIs (Indicate how performance will be measured: indicators, activities…) In accordance with departmental objectives such as support of projects with agreed quality and delivery dates, passing of internal and external inspections. Maintain sound working relationship with internal customers and external partners. Meet quality and timelines in all projects. Act in accordance with Novartis standards in particular; cGMP, ethical, health safety and environment (HSE), and information security (ISEC). EEO Statement The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential. Minimum requirements Education: Minimum: Basic degree in science or relevant discipline (BSc or equivalent). Desirable: Advanced degree in science of relevant discipline (MSc or equivalent). Languages: Fluent English required (oral & written). Good skills in site (local) language desired (oral). Experience: Good knowledge of cGMP, working knowledge in technical development, production or QA. Sound scientific, technical and regulatory knowledge. Broad working experience (approx. 5 years) in technical drug development, production, QC or QC. Strong organizational and decision-making skills. Strong and proven ability to analyze and evaluate cGMP compliance. Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. 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: Division Global Drug Development Business Unit QA GDD Country USA Work Location Fort Worth, TX Company/Legal Entity Novartis Pharmaceuticals Functional Area Quality Job Type Full Time Employment Type Regular Shift Work No Early Talent No
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