QA Manager

Position Summary

Aeris Dynamics Pte Ltd is a Singapore-based pharmaceutical cold chain SME. The role will take ownership of the company’s Quality Management System (QMS), provide day-to-day leadership and technical guidance to the QA Engineer, and help build the quality systems needed to support the company’s growing pharmaceutical customer base.

The role is hands-on and covers both quality management and day-to-day QA/QC activities, including packaging qualification and validation testing. It is suited to a QA Supervisor or experienced QA Specialist who is ready to take on broader responsibility for the QMS, quality operations, and team development.

The immediate focus is on strengthening the company’s existing quality systems and processes. The role will also ensure that these systems can be developed toward Good Distribution Practice (GDP) requirements in the future as business and customer requirements evolve.

Key Responsibilities

Quality Management System (QMS)

• Take ownership of the company’s QMS, including SOPs, document control, quality records, and related processes.
• Review and improve the QMS to ensure it remains practical, effective, and aligned with pharmaceutical industry and regulatory expectations.
• Establish and manage the CAPA and deviation systems, including root cause analysis and follow-up on corrective and preventive actions.
• Develop the QMS with future GDP requirements in mind, without implementing a full GDP system before it is required.
• Manage the internal audit programme and ensure the company remains prepared for customer and regulatory audits.

GDP Readiness

• Maintain working knowledge of GDP requirements relevant to pharmaceutical cold chain distribution.
• Keep up to date with relevant requirements from HSA, PIC/S, and other applicable regulatory bodies in Singapore and the region.
• Advise management on quality system decisions that support future GDP compliance.
• Lead GDP implementation if the company later needs to meet specific customer, licensing, or regulatory requirements.

Hands-On QA/QC and Testing

• Perform and review QA/QC activities, including packaging qualification and validation testing.
• Conduct or oversee testing such as thermal performance testing, temperature mapping, and packaging integrity testing.
• Review and approve validation protocols and reports.
• Provide technical guidance on complex or non-standard testing and validation work.
• Ensure test equipment is properly calibrated and that testing methods provide appropriate accuracy and traceability.

Customer and Regulatory Audits

• Support pharmaceutical customer audits, supplier quality questionnaires, and quality agreements.
• Prepare the company for regulatory inspections and third-party audits.
• Coordinate audit responses and follow up on findings and corrective actions.
• Work with Sales and Business Development to address quality requirements when onboarding new pharmaceutical customers.

CAPA and Continuous Improvement

• Review CAPA and deviation trends to identify recurring or higher-risk quality issues.
• Lead improvements to QA/QC processes, testing methods, and QMS documentation.
• Report quality performance, audit findings, CAPA status, and improvement activities to management.

Team Leadership

• Provide day-to-day supervision, guidance, and technical support to the QA Engineer.
• Coach and develop the QA team through structured training and practical exposure to pharmaceutical quality standards.
• Support the QA Engineer’s development in areas such as QMS, GDP, quality testing, and validation.

Cross-Functional Collaboration

• Work closely with Operations, Engineering, and Sales to address quality and compliance requirements.
• Provide quality input to operational and business development initiatives.
• Represent the Quality function in cross-functional improvement projects.

General Responsibilities

• Maintain high standards of professionalism, confidentiality, and ethical conduct.
• Perform other related duties as assigned by management.

Requirements and Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy or a related field.
• At least 7 years of Quality Assurance experience in the pharmaceutical, biotech, pharmaceutical cold chain or logistics industry.
• Experience at QA Supervisor level or as a senior QA Specialist ready to take on broader QMS and team leadership responsibilities.
• Working knowledge of Good Distribution Practice (GDP), preferably gained in a pharmaceutical or GDP-regulated environment.
• Hands-on experience in QC and testing, preferably including packaging qualification or validation.
• Experience supporting or hosting customer and/or regulatory quality audits.
• Supervisory, mentoring, or team leadership experience is preferred. Candidates without formal direct reports but with demonstrated initiative and readiness to lead will also be considered.
• ISO 9001 Lead Auditor, ASQ CQE/CQA, IATA Dangerous Goods Regulations (DGR), or similar certifications are an advantage.
• Strong communication and coaching skills with the ability to develop QA capability within a small and growing team.