Global Quality Systems & Compliance Lead

WUXI XDC SINGAPORE PRIVATE LIMITED; Singapore; On-site; SGD 70,000 - 90,000; Full time

Job summary

A leading biopharma company in Singapore seeks an experienced Quality Manager to establish and maintain an effective quality management system. The role involves ensuring compliance with regulatory requirements, managing GMP documentation, and facilitating training initiatives. The ideal candidate will have at least 8 years of experience in quality management, a Bachelor's degree in a relevant field, and expertise in quality systems for biopharma. Strong communication skills and proficiency in software tools like TrackWise and SAP are essential.

Qualifications

• Minimum 8 years of experience in production and/or quality management.
• At least 5 years in production QA, quality system QA or compliance QA.
• Familiarity with regulatory guidelines like FDA and EMEA.

Responsibilities

• Establish and maintain an effective quality system to ensure compliance.
• Manage the entire GMP documentation lifecycle and ensure accuracy.
• Conduct regular reviews of quality metrics for continuous improvement.

Skills

Effective cross-functional communication

Strong learning ability

Proficient in Microsoft Word

Proficient in Microsoft Excel

Proficient in PowerPoint

Skilled in TrackWise

Skilled in SAP

Proficient in English

Education

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

Tools

TrackWise

SAP

Job description

A leading biopharma company in Singapore seeks an experienced Quality Manager to establish and maintain an effective quality management system. The role involves ensuring compliance with regulatory requirements, managing GMP documentation, and facilitating training initiatives. The ideal candidate will have at least 8 years of experience in quality management, a Bachelor's degree in a relevant field, and expertise in quality systems for biopharma. Strong communication skills and proficiency in software tools like TrackWise and SAP are essential.