Senior Quality Assurance Specialist

JOB OVERVIEW

The Quality Assurance Trainer designs and delivers SOP and quality training to support compliant clinical trial operations across the organization. This role works with QA and cross-functional teams to maintain training materials, deliver engaging sessions in English and Mandarin, and monitor training effectiveness. The position also supports onboarding, refresher training, and continuous improvement within the quality management system.

The trainer ensures that learning content is accurate, role-relevant, and aligned with the company's quality management system, while also supporting onboarding, refresher training, and continuous improvement initiatives.

Besides training assignments, the quality assurance trainer may support quality assurance related activity such as vendor qualification, audit, quality issue management whenever needed.

KEY RESPONSIBILITIES

• Develop and maintain SOP, QA, and compliance training materials.
• Deliver instructor-led and virtual training in English and Mandarin.
• Identify training needs with QA and operational stakeholders.
• Support onboarding, refresher, and change-related training.
• Track training completion, feedback, and effectiveness.
• Maintain accurate and audit-ready training records.
• Update training content following SOP or process changes.
• Support inspection and audit readiness related to training.
• Support QA related assignment whenever needed.

EXPERIENCES, SKILLS AND COMPENTENCIES REQUIRED

This role requires a quality professional with 5+ years of clinical trial experience, ideally within a CRO or other global matrix environment, and the ability to deliver SOP and compliance training effectively.

EXPERIENCE

• Clinical trial experience (Mandatory): 5+ years in clinical research, clinical quality assurance, trial operations, or a related GxP-regulated environment.
• Pharmaceutical/CRO/Health environment (Mandatory): Experience in a CRO, sponsor, or other global matrix organization.
• Training experience (Preferred): Experience developing and delivering SOP, GCP, quality, or process training.

SKILLS

• Regulatory knowledge (Mandatory): Good understanding of ICH-GCP, clinical trial quality principles, and SOP management.
• Bilingual communication (Mandatory): Fluent written and spoken English and Mandarin.
• Training skills (Preferred): Strong presentation, facilitation, and communication skills.
• Systems skills (Preferred): Familiarity with Microsoft Office and training or quality systems.

COMPETENCIES

• Communication: Communicates clearly and effectively with different audiences.
• Organization: Plans work effectively and maintains attention to detail.
• Collaboration: Works well across functions and stakeholders.
• Continuous improvement: Uses feedback and quality trends to improve training outcomes.

EDUCATION REQUIRED

Bachelor's degree in life sciences, pharmacy, nursing, medicine, public health, or a related field is required. Relevant experience may be considered in lieu of a degree where permitted. GCP, quality, or training-related certification is preferred.

LANGUAGE SKILLS

Fluent English and Mandarin are required, with the ability to deliver training and prepare written materials in both languages.