QA Quality Systems & Compliance

WuXi XDC; Singapore; On-site; SGD 80,000 - 120,000; Full time

Job summary

A leading biopharma company in Singapore seeks a Quality Manager. This role involves establishing a quality management system, ensuring regulatory compliance, and managing internal and external audits. The ideal candidate has a Bachelor’s degree in a relevant field and at least 8 years of experience in quality management with strong skills in cross-functional communication and proficiency in various software tools.

Qualifications

• At least 8 years of working experience in production and/or quality management.
• Minimum of 5 years in production QA, quality system QA, or compliance QA.
• Familiarity with FDA, EMEA, HSA, and PIC/S GMP requirements.

Responsibilities

• Establish and maintain an effective quality system.
• Manage the entire GMP documentation lifecycle.
• Oversee quality events management and conduct regular reviews of quality metrics.
• Monitor regulatory compliance and conduct internal and external audits.

Skills

Cross-functional communication

Proficient in English

Learning ability

Education

Bachelor's degree in Biologics or related field

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

TrackWise

SAP

Job description

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.