PSelect how often (in days) to receive an alert : Create Alert /ppuCategory : /u Reg Affairs Safety Pharmacovigilance /ppAt the end of 2024, Novo Nordisk acquired the Catalent Anagni S.r.l. manufacturing site with the ambition of expanding our capacity to meet the needs of millions of patients. You will be joining a global team working on pharmaceutical plants that utilize advanced technologies within the site's fill finish facilities. /ppbAt Novo Nordisk, we don't wait for change—we drive it! /b /ppToday we are looking for a QA Regulatory Compliance Manager to join our team in Anagni and play a key role in ensuring that our quality systems is fully aligned with cGMP, regulatory expectations and patient safety standards. /ppbThe Position /b /ppAs a QA Regulatory Compliance Manager, you will be a key leader within the Quality organization, responsible for ensuring the site's compliance with global regulatory requirements and Good Manufacturing Practices (GMP). Operating in a dynamic, cross-functional environment, you will drive inspection readiness, regulatory compliance, and the continuous improvement of the Quality Management System (QMS), supporting strategic quality initiatives and maintaining a strong compliance culture. /ppbKey Responsibilities /b /pulliHealth Authority (HA) Inspection Readiness : Lead the preparation and coordination of inspections by national and international Health Authorities (e.g., AIFA, FDA, EMA). Ensure implementation of a robust inspection readiness program, oversee response strategies, and manage the development and follow-up of effective CAPA plans. /liliRegulatory Compliance Support : Support site Qualified Persons (QPs) in managing regulatory activities. Coordinate with internal functions to gather and maintain documentation required for product registration, variations, and regulatory submissions. /liliRegulatory Communication Documentation : Manage communications and notifications to regulatory authorities (e.g., AIFA, FDA), ensuring timely and accurate submissions. Own and maintain the Site Master File (SMF), ensuring its continuous alignment with evolving global regulatory expectations. /liliQuality Systems Oversight : Oversee core quality systems including Change Control, Annual Product Quality Review (APQR), internal audit programs, and Periodic Quality Reviews. Ensure accurate data collection and reporting of QA Key Performance Indicators (KPIs). /liliData Integrity Governance : Coordinate the site’s Data Integrity Program. Ensure alignment with corporate quality standards and regulatory expectations. Provide oversight for QMS processes to assure data integrity compliance across all GxP areas. /liliComputer System Validation (CSV) : Oversee validation strategies and plans for GxP-relevant computerized systems in line with global regulations (FDA, EMA). Review and approve validation documentation (IQ / OQ / PQ protocols and reports) to ensure consistency and compliance. /liliQuality Culture Leadership : Champion a proactive quality culture across the site. Provide leadership, training, and support to cross-functional teams to strengthen compliance, enhance inspection readiness, and drive continuous improvement. /li /ulpQualifications Profile /ppbTo be successful in this role, we imagine that you have : /b /pulliUniversity degree in scientific disciplines (e.g., Pharmacy, Chemistry, Biotechnology, Biology, CTF). /liliMinimum of 10 years of experience in Quality Assurance in the pharmaceutical industry, with a strong focus on regulatory compliance, inspection readiness, and QMS. /liliProven experience in Health Authority inspections, including leading preparation, managing inspections on-site, and coordinating post-inspection activities. /liliSolid knowledge of EU (AIFA / EMA) and US (FDA) regulatory requirements, GMP standards, and validation principles (IQ / OQ / PQ). /liliExperience in maintaining and updating the Site Master File, managing the APQR process, and leading internal audits and quality reviews. /liliDemonstrated expertise in Data Integrity compliance and governance of GxP computerized systems. /liliFluent in English with excellent communication and interpersonal skills, capable of interfacing with regulatory authorities and cross-functional teams. /liliStrong leadership skills with the ability to influence, mentor, and guide teams. /li /ulpbAbout the Department /b /ppYou’ll lead a fantastic team made up of 3 direct reports and 7 indirect colleagues, playing a key leadership role within a wider group of 6 QA Managers in different functions. You’ll report directly to the Quality Operations Director and contribute to the growth of a rapidly expanding business unit : currently composed of over 190 passionate professionals dedicated to delivering excellence. /ppbWorking at Novo Nordisk /b /ppAt Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales – we’re all working to move the needle on patient care. /ppbContact /b /ppWe can’t accept directly sent CVs, please submit your application via the ‘Apply’ Button. /ppDeadline /ppbApply before June 18, 2025. /b /ppWe commit to an inclusive recruitment process and equality of opportunity for all our job applicants. /ppAt Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing. /ppJ-18808-Ljbffr /p #J-18808-Ljbffr