Quality Assurance Associate

Role & responsibilities

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

• Bachelors or Masters 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.