Quality Systems & Compliance

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

Job Summary

Establish an effective quality management system and ensure it runs smoothly.

Responsibilities

• Oversee the establishment and maintenance of an effective quality system, ensuring full compliance with the latest regulatory requirements.
• Manage the entire GMP documentation lifecycle (creation/retired, revision, review, issuance, archiving and destruction), ensuring accuracy and control.
• Be responsible for personnel training initiatives.
• Oversee quality events management (deviation, CAPA, change control), ensuring all changes are thoroughly assessed before implementation.
• Conduct regular reviews and assessments of quality metrics to ensure continuous improvement, including trend analysis of quality processes (deviation, CAPA, change control, complaints etc.).
• Establish and implement a comprehensive Quality Risk Management Plan, ensuring timely execution and tracking mitigation efforts (if any) to completion.
• Facilitate regular quality management review meetings in accordance with internal policies.
• Take charge of regulatory surveillance and compliance, continuously monitoring regulatory changes, including but not limited to FDA, EMEA, PIC/S, cGMP, HSA and other relevant guidelines. Lead gap assessments and ensure timely implementation of necessary updates.
• Lead internal audit program by developing audit plan.
• Lead external audits and response to client / regulatory audits and coordinate CAPA implementation.
• Oversee the supplier management program, including quality activities such as supplier qualification (audit and assessment), periodic performance monitoring, supplier change notification, decommissioning, establishing quality agreements to ensure compliance.
• Handle product complaints efficiently.
• Manage product recalls when necessary.
• Perform other tasks assigned by leadership.

Qualifications

• Bachelor's degree or higher in Biologics, Pharmacy, Pharmaceutical Engineering, Bioengineering, or other relevant fields.
• At least 8 years of working experience in production and/or quality management, with a minimum of 5 years in production QA, quality system QA or compliance QA.
• Familiarity with FDA, EMEA, HSA and PIC/S GMP requirements.
• Experience in setting up quality systems for new sites is preferred.
• Experience in leading audits is preferred.
• Experience with biopharma commercial quality systems is preferred.
• Proficient in English listening, speaking, reading, and writing.
• Skilled in Microsoft Word, Excel, PowerPoint, TrackWise, SAP etc.
• Strong learning ability.
• Effective at cross-functional communication and collaboration.