Global Quality Systems & Compliance Lead

WUXI XDC SINGAPORE PRIVATE LIMITED; Singapore; On-site; SGD 100,000 - 130,000; Full time

Job summary

A biotechnology firm in Singapore is seeking a Quality Manager to oversee the establishment and maintenance of a comprehensive quality management system. This role involves ensuring compliance with regulatory guidelines, managing the entire lifecycle of GMP documentation, and conducting regular quality metrics reviews. The ideal candidate should have at least 8 years of experience within production or quality management, with proficiency in English and familiarity with FDA/GMP regulations. Excellent cross-functional communication and leadership skills are essential.

Qualifications

• Bachelor's degree or higher in a relevant field.
• At least 8 years of experience in production/quality management.
• 5 years minimum in QA or compliance QA.
• Familiarity with regulatory GMP requirements.
• Experience in setting up quality systems for new sites preferred.
• Experience leading audits preferred.

Responsibilities

• Establish and maintain an effective quality system.
• Manage GMP documentation lifecycle.
• Conduct training initiatives for personnel.
• Oversee quality events management.
• Implement Quality Risk Management Plan.
• Lead internal and external audits.
• Handle product complaints and recalls.

Skills

Cross-functional communication

Learning ability

Proficient in English

Skilled in Microsoft Word

Skilled in Excel

Skilled in PowerPoint

Experience with TrackWise

Experience with SAP

Education

Bachelor's degree in Biologics, Pharmacy, Pharmaceutical Engineering or related fields

Tools

TrackWise

SAP

Job description

A biotechnology firm in Singapore is seeking a Quality Manager to oversee the establishment and maintenance of a comprehensive quality management system. This role involves ensuring compliance with regulatory guidelines, managing the entire lifecycle of GMP documentation, and conducting regular quality metrics reviews. The ideal candidate should have at least 8 years of experience within production or quality management, with proficiency in English and familiarity with FDA/GMP regulations. Excellent cross-functional communication and leadership skills are essential.