Quality Manager

Coalesce Management Consulting; Singapore; On-site; SGD 120,000 - 180,000; Full time

Job summary

Coalesce Management Consulting is seeking an experienced Quality Manager to oversee quality assurance and control in a GMP-regulated pharmaceutical manufacturing environment in Singapore. You will ensure regulatory compliance, maintain the Quality Management System (QMS), and drive continuous improvement to support manufacturing operations.

You will lead investigations into deviations, manage CAPA, change controls, risk assessments, and regulatory inspections, and collaborate with Manufacturing,

Qualifications

• Bachelor’s degree in Pharmaceutical Sciences or related field.
• Minimum 5–8 years of experience in Quality Assurance/Quality Management in pharma/biopharma.
• Hands-on experience with deviation management, CAPA, change control, risk management, and regulatory inspections.

Responsibilities

• Oversee QA and QC activities to ensure cGMP compliance and internal procedures.
• Maintain and improve the Quality Management System (QMS).
• Lead investigations into deviations and non-conformances; ensure timely CAPA implementation.
• Manage change controls, risk assessments, and quality documentation.
• Support internal/external audits and regulatory inspections; client quality assessments.
• Collaborate with Manufacturing, QC, Engineering, Validation and cross-functional teams.
• Review and approve quality documentation (SOPs, investigation reports, validation protocols).
• Monitor quality KPIs and drive continuous improvement initiatives.
• Provide leadership and training to quality personnel; promote a quality culture.

Skills

Quality management

GMP compliance

CAPA

Deviation management

Change control

Regulatory inspections

Cross-functional leadership

Problem solving

Education

Bachelor's degree in Pharmaceutical Sciences

Job description

We are seeking an experienced Quality Manager to oversee quality assurance activities within a GMP-regulated pharmaceutical manufacturing environment. The successful candidate will be responsible for ensuring compliance with regulatory requirements, maintaining quality management systems, and driving continuous improvement initiatives to support manufacturing operations.

Key Responsibilities

• Oversee and manage quality assurance and control activities to ensure compliance with current Good Manufacturing Practices (cGMP), regulatory standards, and internal quality procedures.
• Maintain and continuously improve the Quality Management System (QMS) to ensure product quality and regulatory compliance.
• Lead investigations into deviations, non-conformances, and quality-related issues, ensuring timely implementation of Corrective and Preventive Actions (CAPA).
• Manage change controls, risk assessments, and quality documentation in accordance with established procedures.
• Support internal and external audits, regulatory inspections, and customer quality assessments.
• Collaborate closely with Manufacturing, Quality Control, Engineering, Validation, and other cross-functional teams to resolve quality-related issues.
• Review and approve quality documentation, including SOPs, investigation reports, validation protocols, and manufacturing records, within the scope of assigned authority.
• Monitor quality performance indicators, identify areas for improvement, and implement effective quality improvement initiatives.
• Provide leadership, guidance, and training to quality personnel to promote a strong quality and compliance culture.
• Ensure timely escalation and resolution of critical quality issues that may impact product quality, patient safety, or regulatory compliance.

Requirements

• Bachelor's Degree in Pharmaceutical Sciences, Chemistry, Biotechnology, Life Sciences, Chemical Engineering, or a related discipline.
• Minimum 5–8 years of relevant experience in Quality Assurance or Quality Management within the pharmaceutical or biopharmaceutical industry.
• Demonstrated experience in managing quality systems and leading quality-related activities within a GMP-regulated manufacturing environment.
• Strong knowledge of cGMP requirements, pharmaceutical quality systems, and applicable regulatory standards.
• Hands-on experience with deviation management, CAPA, change control, risk management, and regulatory inspections.
• Experience in leading and developing quality teams would be advantageous.
• Strong analytical, problem-solving, stakeholder management, and communication skills.
• Ability to manage multiple priorities and work effectively with cross-functional stakeholders.

Additional Information

• This is a contract position.
• Candidates with experience in pharmaceutical or biopharmaceutical manufacturing quality systems are encouraged to apply.