Quality System & Compliance QA

Wuxi Biologics Biopharmaceuticals Singapore Private Limited; Singapore; On-site; SGD 80,000 - 120,000; Full time

Job summary

A leading biopharmaceutical company in Singapore is seeking a Quality Systems Manager to establish and oversee compliance with GMP regulations. Key responsibilities include managing quality systems, developing training programs, and conducting audits. Candidates should have a Master’s degree and extensive experience in quality systems management in the pharma sector.

Qualifications

• 10+ years of QA experience in pharma/biopharma.
• 5+ years in quality systems management.
• Expertise in EU/US/China GMP regulations.

Responsibilities

• Establish and maintain CDMO quality systems.
• Oversee GMP document lifecycle and compliance.
• Develop and deliver quality training programs.

Skills

Quality processes analysis

GMP compliance

Document management

Root cause analysis

Data visualization

Education

Master’s degree in Pharmaceutical Engineering or related field

Tools

MasterControl

Veeva

Power BI

MS Office

Job description

Lead the establishment, maintenance, and continuous improvement of CDMO quality systems to ensure site is compliance with EU, US, China GMP and relevant regulations (e.g.: HSA).

Responsible for maintaining the GMP document & computerized system management

Manage GMP document lifecycle (drafting, review, issuance, archiving, destruction) with data integrity compliance.

Maintain electronic document systems (e.g., MasterControl) and lead system roll‑out & training.

Prepare audit‑ready documents and manage electronic record storage for client audits.

Oversee GMP document archives management to ensure storage compliance with Data Integrity (DI) requirements, including document categorization, access control, and environmental monitoring.

Responsible for training management

Develop GMP training programs and monitor compliance/efficacy.

Deliver quality system training (e.g., deviation management, data integrity) to cross‑functional teams.

Collaborate with global quality teams to align local practices with corporate standards.

Responsible for Quality System & Compliance

Review, approve, and analyze trends of quality processes (deviations, change controls, CAPA, complaints) to ensure closed‑loop management.

Monitor KPIs/ KQIs (e.g., deviation extension rate, recurring deviation rate) and drive root cause analysis for continuous improvement.

Develop and maintain quality system documents (e.g., QRM, APQR).

Responsible for GMP audit and Remediation

Lead responses to client/regulatory audits and coordinate CAPA implementation.

Lead internal audit program and develop audit plan.

Lead supplier audit and assessments for compliance.

Requirements

Master’s degree or above in Pharmaceutical Engineering, Pharmacy, or related field.

10+ years of QA experience in pharma/biopharma, with 5+ years in quality systems management.

Expertise in EU/US/China GMP regulations and computerized system validation (GAMP 5).

Experience in CDMO or big pharma quality system & facility setup preferred.

Proficient in document management systems (e.g., Veeva) and MS Office; data visualization skills (Power BI) preferred.

Fluent English writing/reading skills for SOPs, audit reports, and global communication.