Risk & Compliance Expert - Controls Assurance

2 - 6 years

0 Lacs

Posted:1 week ago| Platform: Shine logo

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On-site

Job Type

Full Time

Job Description

The Digital Risk & Compliance Expert Controls Assurance will be responsible for driving the execution of assessment and testing campaigns such as GxP Periodic Reviews & Third Party Assessments within the Digital Risk & Compliance team. Your impact will extend beyond the team as you support the Digital transformation objective of halving the time from discovery to therapy by ensuring Risk & Compliance at the speed of the business. In this role, you will have the opportunity to work in an international environment as part of a dynamic team, empowered to propose and implement innovative ideas. You will collaborate with diverse business teams and vendors, gaining hands-on experience and contributing to the improvement of controls mitigating Digital risks. Your main responsibilities will include conducting activities related to the execution of GxP Periodic Reviews with a critical thinking mindset, supporting the operational elements of the process, identifying compliance risks, evaluating designed controls, and leading the improvement process. Additionally, you will be involved in supporting the execution of third party quality assessments and audits, identifying compliance risks, evaluating controls, and presenting findings to the Third Party Audit team. The role requires a Bachelor's degree in a scientific, engineering, or Digital/IT discipline, along with 4+ years of experience in Audit/Quality Assurance/inspection in regulated GxP computerized systems environments. You should also have 4+ years of experience in Quality Management, Computerized Systems compliance, or Information Technology contributing to regulated projects, in addition to 2+ years of experience working in the Life Sciences industry. Soft skills such as stakeholder management, adaptability, critical-thinking, problem-solving, leadership, communication, and relationship-building are essential. You should be results-driven, proactive, autonomous, and have a high level of assertiveness. Technical skills required include Audit/Quality Assurance/inspection experience, understanding of relevant life sciences IT risk domains and controls, knowledge of quality management & compliance, industry standards, and IT lifecycle approaches. Fluency in English is mandatory for this position, and you will be expected to demonstrate behaviors like Stretch, putting the interest of the organization first, acting in the interest of patients and customers, and taking action. Skills such as Strategic Thinking, Result Orientation, Relationship, and Influence will also be assessed during the interview process.,

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