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EDUCATION:

• A minimum of a Bachelor degree is required. An advanced degree is preferred.

• Monitoring compliance risk and ensuring mitigation/remediation actions are defined.
• Monitoring progress and confirming effectiveness of remediation plans, by performing Quality Control (QC) checks or special investigations and plan, prepare, conduct, and report QC checks and compliance assessments to ensure risk signals are addressed in a timely manner. More specifically perform the following risk-based activities:
• Conducting compliance monitoring visits.
• Performing assigned reviews of Trial Master File, training compliance documentation and other checks per CRM Integrated Quality Plan for the trial.
• Planning and execution of local QC checks
• Supporting and advising local and central study teams in root cause analysis of significant observations.
• Ensuring appropriate filing of the QC reports.
• Supporting Quarterly Quality Reviews with local Global Clinical Operations (GCO) management addressing compliance issues and risk signals.
• Collaborating with local and central business partners to facilitate (local) inspections and office audits as needed.
• Collaborating with local and central business partners in a timely CAPA setting and implementation.
• Providing CAPA Champion support.
• Supporting the local impact assessment of global procedural documents and if applicable support development and management of associated local procedural documents.
• Supporting onboarding of new hires.
• Managing local workshops to support Quality Management Systems (QMS) and compliance awareness, Lessons Learned, etc.
• Providing advice regarding SOP, system and Good Clinical Practices (GCP) questions of moderate complexity.
• Supporting managing risk at the country level, including assessing root causes and developing effective actions to mitigate risk.
• Performing impact assessments of new/revised local regulations, guidance, and standards.
• Supporting central functions in ensuring local intelligence is up to date (e.g., Country Level Regulatory Requirements-CLRR).
• Supporting Local Operating Company (LOC) Management Review in collaboration with LOC Commercial Quality partners.
• Supporting local suppliers’ assessments as appropriate.Supporting annual Due Diligence update, certification, and training of local suppliers, if applicable.