Senior Product Quality Executive

Prestige Biopharma Group (Prestige Biopharma / Prestige Biologics); Singapore; On-site; SGD 150,000 - 220,000; Full time

Job summary

Prestige Biopharma Group in Singapore seeks an experienced QA leader to drive QMS adoption and regulatory compliance across its CMOs. You will oversee OOS investigations, CAPA workflows, and critical document reviews to support product disposition and commercial readiness.

You will manage complaint handling, lead internal and external audits, and mentor junior QA staff, ensuring ongoing inspection readiness and robust quality systems across bioprocess operations.

Qualifications

• 6–8+ years in biopharma quality assurance with emphasis on product quality management.
• Experience leading QA investigations and compliance activities.
• Proven track record with external CMOs and scale-up processes.

Responsibilities

• Lead implementation of QMS per internal policies and global standards.
• Manage quality operations across CMOs with QTA and compliance.
• Oversee OOS investigations and CAPA-driven resolutions.
• Review and approve critical QC and process documents for disposition.
• Manage complaint workflows and trend reporting for management.
• Lead internal audits and participate in external audits.
• Provide cross-functional training and mentor junior staff.

Skills

QMS implementation

QA leadership

OOS investigations

CAPA management

Regulatory compliance

CMO management

Training & mentoring

Education

Engineering degree (Biomedical / Bioprocess)

Science degree (Biology / Chemistry)

Tools

Bioprocessing technology

Job description

• Lead in the implementation of Quality Management System in accordance with internal company policies and procedures, cGMP and global regulatory standards.
• Manage quality operations and compliance across designated contract manufacturing organizations, ensuring adherence to Quality Technical Agreements.
• Oversee complex Out-Of-Specification (OOS) investigations, major deviations, and risk management reviews, ensuring timely escalation and resolution through the CAPA system.
• Review and approve critical product quality documents, including test protocols, analytical reports, batch records, and process consistency data to support product disposition and commercial readiness.
• Manage complaint handling workflows from various sources into the log, ensuring timely reviews, investigations, and metric trend reporting for management.
• Lead internal audit programs to ensure QMS effectiveness and participate in external CMO/CRO audits to verify ongoing compliance and inspection readiness.
• Provide cross-functional training on quality procedures and best practices, while actively mentoring junior QA staff to support their professional development.

Education/Qualification

• Degree in Engineering (Biomedical, Bio process engineering) or Science (Biology, Chemistry).
• Industry Experience: 6 to 8+ years of progressive experience in biopharmaceutical quality assurance, with a strong emphasis on product quality management, investigations, and compliance.
• Technical Background: Hands-on familiarity with Bioprocessing Technology, covering both upstream and downstream operations.
• Operational Skills: Demonstrated experience managing external manufacturing partners (CMOs), navigating technical deviations, and aligning quality workflows with commercial scale-up.