Quality & Compliance Oversight
- Establish and maintain QMS and ISMS in compliance with ISO standards and regulatory requirements.
- Prepare, review, and update SOPs to reflect changes in regulations, business needs, and process improvements.
- Ensure SOP compliance across departments through training, monitoring, and periodic reviews.
- Review risk assessments and implement effective risk mitigation strategies.
- Oversee computer system validation (CSV) activities and review software validation documentation to ensure GxP compliance.
Audit, Inspection, Deviation & CAPA Management
- Support and manage internal, project, and vendor audit programs.
- Support sponsor audits and regulatory inspections, including documentation handling and follow-up activities.
- Track and report audit findings, CAPA metrics, and quality indicators to senior management.
- Support the identification, documentation, and investigation of quality deviations.
Clinical Data Oversight
- Collaborate closely with CDM, CDISC, and Biostatistics teams to ensure data integrity and regulatory compliance.
- Support data review activities, including SDV, PK and statistical analysis, SDTM and ADaM Datasets, TLFs, SAP, Mockshells.
Regulatory & Client Engagement
- Liaise with sponsors, clients, and regulatory authorities as needed.
- Support regulatory reporting activities and ensure proper documentation for internal teams and clients.
- Track and document cases involving scientific misconduct, serious breaches, and risk events.
Management Review & Continuous Improvement
- Analyse audit results, process performance, nonconformities, and opportunities for improvement.
- Provide regular reports on key quality indicators and support strategic decision-making.
- Conduct training sessions to promote a culture of quality and compliance across teams.
Training & Continuous Improvement
- Conduct training sessions for staff on QMS, ISMS, applicable standards, and regulations.
- Identify process improvement opportunities and support operational teams in issue resolution.
Qualifications & Skills
- Bachelor's or Master's degree in Life Sciences, Quality Management, or related field.
- Minimum 1+ years of experience in quality assurance within clinical research.
- Strong knowledge of ISO 9001, ISO 27001, ICH-GCP, CDISC standards, and clinical data workflows.
- Proven experience in deviation management, audit hosting, and QMS implementation.
- Excellent communication, and analytical skills.
- Proficiency in quality tracking systems and documentation tools.
Skills: clinical data,qms,documentation,iso,capa,compliance
