QA 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

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