Global Regulatory Affairs Quality & Process Specialist Parma

Global Regulatory Affairs Quality & Process Specialist
Parma
Emilia Romagna, Parma

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 Responsibilities Oversee GRA quality system documentation, maintenance, and compliance activities including: Ensuring compliant a training plan is created, applied, and maintained throughout GRAManage GRA related deviations and correction action and preventive action plan (CAPA) as neededEnsure GRA Manual, Standard Operative Procedure (SOP), and Working Instruction (WI) implementation and continuous improvementEstablish and ensure cross-functional (GPV, GMD, and GCD) communication flows related to GRA activities. Oversee audit and inspection related activity, as needed based on GRA involvement, including ensuring coordination of pre-audit/inspection activities, participating in audits/inspections as needed and coordination of any post-audit/inspection CAPAs. 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 as needed. Oversee Regulatory operational activities for the Therapeutic Areas (TAs) ensuring appropriate cross-functional support is provided to allow regulatory requirements and internal standards to be met to support the success of drug development programs. Initiate cross-TA events within Regulatory Information Management System (RIMS). 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, including the identification and appointment of alternatives (i. e.

external consultancy) as needed. Experience RequiredA minimum of 5 years experience in Regulatory Affairs.

In-depth knowledge of drug development and regulatory procedures.

EducationLife science degreeLanguagesEnglish fluentTechnical SkillsKnowledge of Regulatory Affairs procedures 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, that is why we invest in continuous training, learning and development.

Therefore, we strive to continuously promote and satisfy development needs, paying particular attention to the quality of our working environment and to collective well-being. We want our people to come to work happy every day, and we know how important it is to find the right work-life balance in order to be able to give our best.

That is why we offer flexible working approach, remote working, support in the relocation process, tax assistance service for foreign colleagues and many other people-care services.