Key Responsibilities: Collaborate with the Clinical Affairs team to ensure compliance during trial activities, such as resolving deviations and complaints. Represent Clinical QA as part of project teams for planned and ongoing clinical trials, including quality review of trial-related documentation. Support the qualification process and perform independent QA audits of clinical study sites. Participate in the internal audit program. Review and update Clinical Affairs SOPs. Position Requirements: Degree qualification in a relevant field or equivalent work experience. Proven experience and knowledge of clinical regulations, standards, guidelines, and best practices (e.g., CFR 812, BIMO, ISO standards, ICH GCP). Solid understanding of global In Vitro Diagnostic Regulations (e.g., EU IVDR, US 21CFR820). Ideally a qualified auditor with experience serving as a Subject Matter Expert during regulatory inspections and formal audits (e.g., NB audit). Willingness to travel internationally (up to 10%, including Europe and the US). Ability to work independently with good judgment and decision-making within established policies and practices. Strong communication and interpersonal skills, with the ability to work effectively in multinational and multicultural teams.