Kerja Sepenuh Masa, Quality Manager di Coalesce Management Consulting - Maukerja

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.