QA - Product Quality Manager

2 mesi fa


Rome, Italia Merck A tempo pieno
Work Your Magic with us

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.Your role:You will manage a Quality Operations team dedicated to product program management with focus on both development activities and Life Cycle Management. You will be in charge of ensuring compliance of product related activities with international GMP standards, applicable ICH guidelines, Company quality standards and procedures, balancing the phase appropriateness in the frame of pharmaceutical development. To this end you will manage a team of professionals taking care of site programs activities, in all phases of product development, analytical development and quality control activities, interacting with multifunctional working groups and supporting QP function in clinical purpose release process. You will coordinate the active contribution to project team meetings, identifying and solving any risk, issue and need coming from stakeholders (internal and external). You will be asked to empower people to promote change and innovation to achieve continuous improvement, with a strong focus on building networking in the frame of Development Quality and Global CMC Development flows. You will cooperate to Quality Risk Management maturity program and to Quality Culture initiatives. You will be part of audits from Health Authorities and Customer preparation and execution assuring inspection readiness in program execution. As a team manager you will drive engagement, performance and results of your team as well as people development, being active part of quality culture dissemination. You will report to the Director, Head of Site Quality Who you are: Master’s Degree in Pharmaceutical Chemistry, Pharmacy or equivalent >5 years of experience in pharmaceutical industry Excellent knowledge of quality management, cGMP and Health Authorities requirements

Previous experience in complex organizations and international networks is a plus Fluent in spoken and written English Prominent managerial and leadership skills Eligible to Qualified Person role a plus Frenck or German knowledge as a plus What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress Apply now and become a part of our diverse teamJob SummaryJob number: 278955Date posted : 2024-09-12Profession: QualityEmployment type: full-timeType: external

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