Job Description
Job Summary
The Assistant Manager Global QMS is responsible for supporting the implementation, maintenance, and continuous improvement of the Global Quality Management System (QMS) across all sites, ensuring compliance with applicable regulatory requirements and company standards.
Key Responsibilities
Ensure effective implementation and ongoing compliance of the Quality Management System (QMS) across all sites in line with regulatory and internal standards.
Review and approve quality documents including SOPs, policies, change controls, deviations, CAPAs, and risk assessments.
Monitor regulatory compliance with applicable guidelines and regulations such as GMP, ISO, ICH, FDA, WHO, and relevant local regulatory requirements.
Track regulatory commitments and ensure timely closure of agreed actions.
Support and participate in internal audits, external audits, and regulatory inspections.
Perform trend analysis of quality events including deviations, complaints, OOS/OOT, and assess CAPA effectiveness.
Coordinate with site QA teams to ensure consistent interpretation and implementation of quality standards across the organization.
Support management review meetings by preparing quality metrics, dashboards, and periodic quality reports.
Drive continuous improvement initiatives within the Global QMS framework.
Qualifications & Experience
Education: M.Sc. or M.Pharm
Experience: 9 to 12 years of relevant experience in Quality Assurance / Global QMS within pharmaceutical, biotech, or regulated industries
Key Skills & Competencies
Strong knowledge of global QMS and regulatory requirements
Good understanding of GMP and quality systems
Analytical and problem-solving skills
Strong documentation and communication skills
Ability to work collaboratively with cross-functional and multi-site teams
