Associate Clinical Quality Operations Manager, Oncology III

Job Title: Associate Clinical Quality Operations Manager, Oncology III Job Location: Lima, Peru Job Location Type: Remote Job Contract Type: Full-time Job Seniority Level: Job Description The Associate Clinical Quality Operations Manager (ACQOM) plays a key role in ensuring our company receivesconsistent, accurate, and high-quality clinical trial data worldwide. Working closely with the Clinical Quality Operations Lead (CQOL) and Head of CQO, the ACQOM supports operational quality management, risk management, inspection readiness, supplier oversight, and continuous quality improvement within assigned therapeutic areas. Key Responsibilities Clinical Trial Quality Support - Support Clinical Trial Teams embedding Quality by Design (QbD) principles throughout clinical development programs. - Conduct quality control activities to identify emerging study risks, process gaps, and quality issues. - Review quality documentation and trial quality folders for completeness and accuracy. - Assist with mergers, acquisitions, and integration activities to ensure knowledge transfer, risk mitigation, and inspection readiness. Risk Management - Develop expertise in risk management tools and processes - Review critical data and processes throughout the clinical trial lifecycle to ensure risks are identified, monitored, and mitigated. Regulatory Inspection Readiness - Support sponsor and investigator-site inspections and help maintain ongoing inspection readiness. - Participate in Inspection Support Teams (ISTs). - Manage and track Corrective and Preventive Actionsand regulatory commitments through completion. - Perform quality reviews of inspection documentation repositories and support inspection response development. - Analyze inspection outcomes for trends and lessons learned. Quality Assurance Audits - Assist with audit preparation, facilitation, root cause analysis, response development, and CAPA management. - Provide project management support for audit-related activities and CAPA implementation. Third-Party Supplier Oversight - Support oversight of clinical research vendors and suppliers to ensure compliance and quality performance. - Assist with quality agreements, audits, inspections, performance monitoring, issue resolution, risk management, and CAPA development. CQO Infrastructure and Continuous Improvement - Contribute to process innovation and improvement initiatives. - Develop advanced knowledge of global Good Clinical Practice (GCP) requirements, including ICH, FDA regulations, and EMA Clinical Trial Regulations . Education - Bachelor's or Master's degree (or equivalent) in a relevant healthcare, life sciences, or related field. - Additional formal education or certification in Quality Management or Business Management is preferred. Experience - Minimum 4 years of experience in the pharmaceutical industry and/or clinical research. - Knowledge of quality management and risk management methodologies is desirable. - Understanding of clinical development programs and clinical trial processes . - Experience with Quality Management Systems (QMS) . - Strong knowledge of Good Clinical Practice (GCP), ICH guidelines, and global regulatory health authority requirements . - Prior experience conducting root cause analysis and managing Corrective and Preventive Actions (CAPAs) . Key Skills & Competencies Communication & Collaboration - Excellent verbal and written communication skills in a global environment. - Strong teamwork and leadership abilities. - Skilled in conflict resolution and handling sensitive matters with discretion. - Ability to influence stakeholders and collaborate effectively across all organizational levels. Leadership & Project Management - Strong project management and organizational skills. - Ability to lead cross-functional teams within and outside the organization. - Capable of driving initiatives and achieving results throug