Global Regulatory Affairs Quality Process Specialist - TemporaryJoin to apply for the Global Regulatory Affairs Quality Process Specialist - Temporary role at Chiesi USA, Inc.About UsBased in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years’ experience, operating in 31 countries with more than 7,000 employees. To achieve its mission of improving people’s quality of life by acting responsibly towards society and the environment, the Group researches, develops, and markets innovative drugs in its main therapeutic areas. We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification, a recognition of high social and environmental standards.Who We Are Looking ForPurposeResponsible for ensuring adequate compliance and management of the GRA quality systems, processes, operational activities, and project coordination according to internal and external requirements.Main ResponsibilitiesOversee GRA quality system documentation, maintenance, and compliance activities including:Ensuring compliant training plans are created, applied, and maintained throughout GRA.Manage GRA related deviations and correction action and preventive action plans (CAPA) as needed.Ensure GRA Manual, Standard Operating Procedure (SOP), and Working Instruction (WI) implementation and continuous improvement.Establish and ensure cross-functional (GPV, GMD, and GCD) communication flows related to GRA activities.Oversee audit and inspection related activity, including coordination of pre-audit/inspection activities and participation in audits/inspections as needed.Ensure GRA Key Performance Indicators (KPIs) are provided in a timely manner.Provide process-related support for GRA projects including impact assessment of quality documents and process mapping.Oversee Regulatory operational activities for the Therapeutic Areas (TAs) ensuring appropriate cross-functional support is provided.Manage and promote appropriate communication on GRA Quality and Process related activities/projects and HA regulations.Collaborate with Department Head on GRA Quality and Process budget related items.Experience RequiredA minimum of 5 years experience in Regulatory Affairs. In-depth knowledge of drug development and regulatory procedures.EducationLife science degree.LanguagesEnglish fluent.Technical SkillsKnowledge of Regulatory Affairs procedures and deep knowledge of the full drug development process, regulatory legislation, and quality requirements.Soft SkillsCommunication skillsDigital mindsetPlanning and organizational skillsStrategic thinkingTeam workingWhat We OfferYou would join a dynamic, fast-growing, challenging, and friendly environment. In Chiesi, we firmly believe that our people are our most valuable asset, which is why we invest in continuous training, learning, and development. We strive to promote and satisfy development needs, paying particular attention to the quality of our working environment and to collective well-being.Seniority levelMid-Senior levelEmployment typeFull-timeJob functionLegalIndustriesPharmaceutical Manufacturing
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