Manager of Quality Management Systems

Job Summary:

This position for Manager of Quality Management Systems (QMS) will ensure compliance with Good Distribution Practices (GDP), 21 CFR regulations, and other applicable standards in a warehouse environment specializing in clinical trial supplies. This role involves implementing, monitoring, and enhancing quality systems to maintain regulatory compliance and ensure operational excellence.

Essential Duties and Responsibilities:

• Manage and oversee the QMS processes, including documentation, control, and implementation of policies and procedures in compliance with GDP, 21 CFR, and industry standards.
• Conduct routine internal & external audits of warehouse operations to ensure adherence to quality guidelines, regulatory requirements, and standard operating procedures (SOPs).
• Coordinate and manage deviation investigations, CAPA (Corrective and Preventive Actions), change control processes and Risk Assessments.
• Ensure Vendor/Customer Verification & Qualification on a timely basis
• Accurate documentation check for each transaction and assure it has been carried out for the inbound and outbound by the operation team.
• Ensure accuracy and effective maintenance of the eQMS portal for all quality-related documentation and activities.
• Reviewing and Authorizing Quality related documents and agreements.
• Prepare and review quality documentation such as SOPs using eQMS portal, validation protocols, and training records to ensure they meet regulatory and organizational standards.
• Support regulatory inspections, internal audits, and customer audits by providing necessary documentation and ensuring compliance readiness.
• Monitor and evaluate the effectiveness of QMS processes through metrics and reporting, identifying areas for improvement.
• Conduct training sessions for staff on QMS policies, GDP requirements, and regulatory compliance.
• Collaborate with cross-functional teams, including warehouse operations, logistics, and regulatory affairs, to address quality-related issues and implement improvements.
• Training the operation team personnel in the warehouse.
• Stay updated on evolving regulatory requirements and incorporate changes into QMS practices.
• Yearly review on the SOPs if any changes need to be made and upgrade the processes.
• All documents record should be kept in controlled and secured manner.

Work Experience Qualifications:

• Proven 5 years of work experience in QMS role within the Pharmaceutical Industry.
• Result driven orientation having solid customer service attitude with excellent negotiation skills.
• Previous experience in SAP & MS Office will be an added advantage.
• Must have keen attention to detail and possess proper phone and email etiquette.
• Ability to stay organized while effectively prioritizing multiple projects at once.
• High attention to detail when completing projects.
• Should be in position to travel for meetings and exhibition events.
• Strong time management skills to complete projects by deadlines.
• Self-motivated individual who takes ownership of their projects.
• Administrative skills (MS Office and Google Workspace are required).
• Maintain excellent verbal, writing, and language skills.