Job
Description
Role Overview: As a Digital Risk & Compliance Expert Controls Assurance at Sanofi, your role will involve driving the execution of assessment and testing campaigns such as GxP Periodic Reviews and Third Party Assessments. You will be part of the Digital Risk & Compliance team, working towards demonstrating risk & compliance health across critical digital solutions to protect patient safety and contribute to Sanofi's growth. Your impact will extend beyond the team as you support the Digital transformation efforts with a focus on accelerating the time from discovery to therapy. This role offers the opportunity to work in an international environment, collaborate with diverse business teams and vendors, and propose innovative ideas. Key Responsibilities: - Conduct activities related to the execution of GxP Periodic Reviews with a high level of expertise and critical thinking mindset - Support the operational elements of the GxP Periodic Reviews process - Identify compliance risks and areas of improvement, evaluating the adequacy of designed controls with a continuous improvement mindset - Lead the improvement of the GxP Periodic Reviews process, exploring synergies with other controls assurance functions and enabling transformation and automation - Ensure proper and timely reporting of GxP Periodic Reviews plan progress via the maintenance of dedicated KPIs - Support the execution of third party quality assessments and audits, identifying compliance risks and areas of improvement, and evaluating the adequacy of designed controls Qualifications Required: - Bachelor's degree in a scientific, engineering, or Digital/IT discipline - 4+ years of experience in Audit/Quality Assurance/inspection in regulated GxP computerized systems environments - 4+ years of experience in Quality Management, Computerized Systems compliance, or Information Technology related to regulated projects or system lifecycle activities - 2+ years of experience in the Life Sciences industry - Soft skills: Stakeholder management, adaptability, critical-thinking, problem-solving, leadership, communication, interpersonal skills, proactivity, and autonomy - Technical skills: Audit/Quality Assurance/inspection experience, understanding of relevant life sciences IT risk domains and controls, knowledge of quality management & compliance, industry standards, and regulations applicable to computerized systems Additional Details: Based on prior experience, upskilling opportunities will be provided to the selected applicant. The position requires excellence in written and oral communication in English, along with behaviors such as Stretch, acting in the interest of patients and customers, and demonstrating skills like Strategic Thinking, Result Orientation, Relationship, and Influence. (Note: The section with Sanofi Behaviors and Skills has been omitted as it is not directly related to the job description) Role Overview: As a Digital Risk & Compliance Expert Controls Assurance at Sanofi, your role will involve driving the execution of assessment and testing campaigns such as GxP Periodic Reviews and Third Party Assessments. You will be part of the Digital Risk & Compliance team, working towards demonstrating risk & compliance health across critical digital solutions to protect patient safety and contribute to Sanofi's growth. Your impact will extend beyond the team as you support the Digital transformation efforts with a focus on accelerating the time from discovery to therapy. This role offers the opportunity to work in an international environment, collaborate with diverse business teams and vendors, and propose innovative ideas. Key Responsibilities: - Conduct activities related to the execution of GxP Periodic Reviews with a high level of expertise and critical thinking mindset - Support the operational elements of the GxP Periodic Reviews process - Identify compliance risks and areas of improvement, evaluating the adequacy of designed controls with a continuous improvement mindset - Lead the improvement of the GxP Periodic Reviews process, exploring synergies with other controls assurance functions and enabling transformation and automation - Ensure proper and timely reporting of GxP Periodic Reviews plan progress via the maintenance of dedicated KPIs - Support the execution of third party quality assessments and audits, identifying compliance risks and areas of improvement, and evaluating the adequacy of designed controls Qualifications Required: - Bachelor's degree in a scientific, engineering, or Digital/IT discipline - 4+ years of experience in Audit/Quality Assurance/inspection in regulated GxP computerized systems environments - 4+ years of experience in Quality Management, Computerized Systems compliance, or Information Technology related to regulated projects or system lifecycle activities - 2+ years of experience in the Life Sciences industry - Soft skills: Stakeholder management, adaptability, critical-thinking, problem-solving, lead
