Quality Systems Manager

We are seeking an experienced Quality Systems Manager to oversee, govern, and maintain the Quality Management System (QMS) across our biopharmaceutical and vaccine manufacturing operations at GSK Singapore. In this critical compliance leadership role, you will drive cGMP adherence, oversee site audit readiness, manage continuous improvement programs, and enforce global quality standards in compliance with international health authorities (including HSA, US FDA, and EMA).

Key Responsibilities

• Quality Management System (QMS) Governance: Oversee site-wide QMS elements, including Deviation Management, Corrective and Preventive Actions (CAPA), Change Control, and Quality Risk Management (QRM) frameworks.
• Regulatory Compliance & Audit Leadership: Act as the primary Quality point-of-contact for regulatory inspections (HSA, FDA, EMA) and internal corporate audits; lead mock audits, gap assessments, and post-audit CAPA tracking.
• Data Integrity & Standard Operating Procedures (SOPs): Ensure site adherence to ALCOA+ data integrity principles and global cGMP standards across paper and electronic batch records.
• Quality Metrics & Management Review: Establish, track, and report Key Performance Indicators (KPIs) and Quality Metrics to senior management during periodic Quality Council reviews to identify system risks and areas for continuous improvement.
• Cross-Functional Supplier Quality & Qualification: Support supplier quality oversight, material qualification, quality agreement reviews, and validation protocols in collaboration with Procurement, Operations, and Regulatory Affairs.

Requirements & Qualifications

• Education: Bachelor’s or Master’s degree in Chemistry, Pharmacy, Biotechnology, Chemical Engineering, or a related scientific discipline.
• Experience: 3+ years of progressive Quality Assurance / Quality Systems experience within a cGMP-regulated biopharmaceutical, vaccine, or medical device manufacturing site, with at least 3+ years in a leadership role.
• Domain Mastery: In-depth knowledge of global regulatory requirements (PIC/S, FDA 21 CFR Part 210/211/11, EU GMP) and quality standards (ISO 9001 / ISO 13485).
• Certifications: Certified Quality Auditor (CQA), Lead Auditor (ISO), or Six Sigma Green/Black Belt certification is highly preferred.
• Leadership & Influence: Strong analytical problem-solving capability (root-cause analysis techniques such as 5 Whys/Fishbone), audit-facing presence, and cross-functional communication skills.

Pay: $9,500.00 - $15,500.00 per month

Benefits:

• Flexible schedule
• Health insurance
• Professional development

Work Location: Hybrid remote in Singapore 618810