ED, Global RLT Quality Operations Lead-US and Europe

AAA StatementAdvanced Accelerator Applications, a Novartis company, is an innovative medicines company focused on the development of products for targeted radioligand therapy and precision radioligand imaging. We are committed to transforming patients'' lives by leading innovation in nuclear medicine. AAA offers professionals the opportunity to face new challenges and pursue a career in a fast growing, technology driven healthcare company. We are passionate about improving patient health by leading innovation in nuclear medicine. We are looking for people who share our commitment to help us achieve this goal. Advanced Accelerator Applications is an Equal Opportunity Employer (EOE).Job Description766 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! Your responsibilities include, but are not limited to: Indianapolis Quality Start-up Lead:• Oversight of quality start-up activities for the new RLT site in Indianapolis IN. • Support site quality head for QMS transition, commissioning and validation QA oversight, and aseptic processing programs. • Support acceleration of site timelines for RLT supply. • Ensure site is Pre-approval Inspection (PAI) ready and achieves successful inspections. Overseeing and leading the Quality function in Americas and Europe Radio Ligand Therapy (RLT) DP sites:• Direct quality oversight of RLT DP sites: Millburn NJ, Indianapolis IN, Ivrea Italy, Saluggia Italy, and Zaragoza Spain.• Ensure that all aspects of the operational business from the sites and the US market comply with the cGMP, Legal and Regulatory requirements and the AAA quality management system as per GMP regulation and corporate guidelines and liaises with the Novartis US Quality organization.• Ensure all aspects of the operational business across the Europe RLT DP sites comply with the cGMPs, Legal and Regulatory requirements and the AAA quality management system as per GMP regulation and corporate guidelines.• Overseeing and leading the construction of the new facility in Indianapolis that will bring a new technology design in the radiopharmaceutical platform with the automatization of lines.• Accountable to lead the Quality strategic and operational activities in US and Europe RLT business.• Ensure the proper Quality organization is in place for the Europe RLT DP sites.• Accountable for the proper Quality organization in the RLT sites being in place. • Manage the Quality budget for Europe and US quality for RLT business. • Ensure implementation, follow up and completeness of all related Quality programs, documentation and Quality reporting. To ensure that the proper escalation and quality incident management process is in place, followed and cGMP-compliant Quality decisions are taken and follow-up is secured.• Accountable for oversight of the radiopharmacies in US that perform the final preparation and distribution of cold kits to the hospitals.• Ensure adequate Health Authority Inspection preparation of the RLT sites and successful inspection outcomes. Policy: While Novartis does not require vaccination at this time, for certain Novartis sites in the US all associates and candidates may be required to either upload an image of their COVID-19 vaccine card demonstrating proof of full vaccination for COVID-19 (or other similar evidence of vaccination) or proof of a negative COVID-19 test taken by the associate or candidate within the past seven days to enter any of our sites and/or customer office or healthcare facility, as well as prior to participating in other work related off-site meetings. Employees working in customer-facing roles must adhere to and comply with customers'' (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to [Click Here to Email Your Resumé].EEO StatementThe 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 requirementsWhat you''ll bring to the role: • Minimum 10 years of experience as Manager in a pharmaceutical Quality Department • Experience as a Site Quality Head• Excellent leadership, organizational (time management, risk management) and communication skills • Knowledge of quality system (GMP and ISO) • Knowledge of regulatory requirements• Experience/knowledge of pharmaceutical market dynamics• Strong leadership and management skills• Strategic thinking• Excellent influencing skills• Problem solving, strong results orientation • Analytical skills• Strong in coaching, building relationships and excellent interpersonal skills • Strong oral/written communications• Proactive, agile and able to overcome significant challenges• Demonstrates strong personal ethics and responsibility to purposeWhy Advanced Accelerator Applications (AAA)?Thousands of people die of cancer around the world every day. At Advanced Accelerator Applications (AAA), a Novartis company, our mission is to transform lives through radioligand therapy in nuclear medicine to fight several leading types of cancer. How will we continue to be on the cutting edge of medicine? We believe new groundbreaking 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!Commitment to Diversity & Inclusion: Novartis embraces diversity, equal opportunity, and inclusion. 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: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 [Click Here to Email Your Resumé] 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 learn more about Novartis and our career opportunities, join the Novartis Network here: /network This employer is a corporate member of myGwork - LGBTQ+ professionals, the business community for LGBTQ+ professionals, students, inclusive employers & anyone who believes in workplace equality.

Created: 2026-03-07