Novartis

At Advanced Accelerator Applications, a Novartis company, we are committed to leading innovation in nuclear medicine and delivering the next generation of targeted radioligand therapy to cancer patients.. Lead cross functional groups and build collaborative interfaces with stakeholders to ensure quality systems such as deviation management, investigations, corrective and preventive actions, change control and complaint management are in place and followed.. Support commercial product FDA/Regulatory interactions for the Carlsbad site activities and products to ensure successful regulatory submissions.. At least 5 years of experience in the pharmaceutical industry with direct experience with Compliance, Quality Systems and sterile manufacturing.. Experience in drug development, clinical, manufacturing, outsourcing and/or other relevant operational areas which must include Quality Assurance

manager quality assurance

About The Role Manager, Quality Assurance Operations Location: Carlsbad, CA About this role: At Advanced Accelerator Applications, a Novartis company, we are committed to leading innovation in nuclear medicine and delivering the next generation of targeted radioligand therapy to cancer patients. We are looking for an experienced Manager, Quality Assurance Operations to help us reach our ambitious goals. The Manager, Quality Assurance Operations is responsible for the quality oversight of Production and Quality Control testing, including final disposition of product. This role ensures that the quality strategy is implemented and that there is a continuous drive to improve product and process quality within the Production Unit at our new radioligand therapy drug product manufacturing facility in Carlsbad. Key Responsibilities: <ul><li>QA oversight of technical activities related to commissioning, qualification, and process validation.</li><li>As the project progresses, this role will transition to providing leadership, daily support, and oversight of GMP operations.</li><li>Support the development of the overall site operational readiness plan including implementation of Quality Systems and Processes to ensure product quality, adherence to GMP and compliance with Novartis standards.</li><li>Support initial recruiting, build capability, for a quality assurance staff to support qualification, validation, and routine production.</li><li>Responsible for overall laboratory readiness activities including equipment qualification, test method validation/co-validation/transfer, test method qualification/verification.</li><li>Lead cross functional groups and build collaborative interfaces with stakeholders to ensure quality systems such as deviation management, investigations, corrective and preventive actions, change control and complaint management are in place and followed.</li><li>Support commercial product FDA/Regulatory interactions for the Carlsbad site activities and products to ensure successful regulatory submissions.</li><li>Oversees the product release process.</li><li>Support escalation management and all commercial product field actions with FDA.</li><li>Ensure consistency of quality related processes and procedures.</li><li>Ensure preparation and delivery of relevant Validation Plans.</li><li>Act as Responsible Person for the final disposition of products. Ensure timely and compliant final product disposition of the Product.</li><li>Ensure the coaching and training of the quality team and other site function’s associates.</li><li>Act as a role model in accordance with RLT and Novartis Values and Behaviors and the leadership standards.</li><li>Actively support audits/inspection management as well as the setup/maintenance of inspection readiness program.</li><li>Support the site to ensure a safe work environment including supporting and leading safety efforts of the quality organization. </li></ul>EEO Statement We 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. Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message: <ul><li>Novartis: e-mail us.reasonableaccommodations@novartis.com or call +1 (877)395-2339</li><li>Sandoz: e-mail reasonable.accommodations@sandoz.com or call: +1-609-422-4098 </li></ul>Role Requirements <ul><li>Bachelor’s degree in relevant Microbiology discipline or equivalent practical experience in Supervision of Microbiology related activities including but not limited to EM monitoring and product testing for microbiology.</li><li>At least 5 years of experience in the pharmaceutical industry with direct experience with Compliance, Quality Systems and sterile manufacturing.</li><li>Previous Managerial experience in Quality Assurance</li><li>Experience in drug development, clinical, manufacturing, outsourcing and/or other relevant operational areas which must include Quality Assurance</li><li>Thorough knowledge of GCP, GMP and PV requirements</li><li>Strong understanding of regulatory Quality Systems requirements</li><li>Proven track record with FDA, EMEA and other Health Authorities</li><li>Strong understanding of risk assessment and risk management fundamentals/tools</li><li>Team building and process harmonization skills.</li><li>Excellent verbal and written communication skills</li><li>Proven leadership skills to drive quality improvement and guide changes.</li><li>Excellent problem solving and decision-making skills. </li></ul>The pay range for this position at commencement of employment is expected to be between $112,800 and $169,200 per year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors 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! Learn more here: https://www.novartis.com/about/strategy/people-and-culture You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook: https://www.novartis.com/careers/benefits-rewards 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. 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 tas.nacomms@novartis.com 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: https://talentnetwork.novartis.com/network Division Operations Business Unit QUALITY Work Location Carlsbad, CA Company/Legal Entity AAA USA Inc. Functional Area Quality Job Type Full Time Employment Type Regular Shift Work No Early Talent No

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