Senior GMP Quality and Regulatory Compliance Lead

WUXI XDC SINGAPORE PRIVATE LIMITED; Singapore; On-site; SGD 80,000 - 100,000; Full time

Job summary

A biotechnology company in Singapore is looking for a Quality Management Specialist to establish and maintain an effective quality system, ensuring compliance with regulatory requirements. The candidate should have at least 8 years of experience in production and quality management, with proven skills in managing documentation and leading audits. Proficiency in English and familiarity with GMP standards are essential. This role requires effective communication and collaboration across functions.

Qualifications

• 8+ years of experience in production/quality management with 5+ years in QA.
• Familiarity with GMP requirements (FDA, EMEA, HSA, PIC/S).
• Experience in establishing quality systems for new sites preferred.

Responsibilities

• Oversee the quality system's establishment and maintenance.
• Manage the GMP documentation lifecycle effectively.
• Conduct regular reviews of quality metrics for continuous improvement.
• Lead the internal audit program and coordinate external audits.

Skills

Effective cross-functional communication

Learning ability

Proficient in English

Education

Bachelor's degree or higher in Biologics or related fields

Tools

Microsoft Word

Microsoft Excel

TrackWise

SAP

PowerPoint

Job description

A biotechnology company in Singapore is looking for a Quality Management Specialist to establish and maintain an effective quality system, ensuring compliance with regulatory requirements. The candidate should have at least 8 years of experience in production and quality management, with proven skills in managing documentation and leading audits. Proficiency in English and familiarity with GMP standards are essential. This role requires effective communication and collaboration across functions.