QA Senior Manager pharmaceutical

1. Job Purpose:
Responsible for developing and managing the overall quality strategy, systems, and compliance processes in accordance with WHO/EU GMP standards, ensuring the highest standards of product quality and regulatory compliance for the manufacturing site.
2. Key Responsibilities:


Develop quality policies and a comprehensive Quality Management System (QMS) for the manufacturing site.


Operate and evaluate the effectiveness of the overall Quality System.


Improve processes and ensure full compliance with WHO/EU GMP.


Guide and develop a quality team that is prepared for regulatory inspections.


Act as a Qualified Person (QP) for product release or delegate in writing when absent.


Review and approve Quality System documents as authorized by the Board of Directors.


Monitor contract manufacturing activities (if applicable).


Conduct Annual Product Quality Reviews and assess the effectiveness of the QMS.


Supervise internal audit implementation and ensure timely execution.


Represent the company in customer audits and inspections by health authorities.


Ensure timely corrective and preventive actions (CAPAs) following audits, and propose preventive and continuous improvement measures.


Oversee adherence to the validation master plan and timely investigation resolution.


Monitor maintenance and repairs of equipment and facilities per GMP requirements.


Manage CAPAs arising from self-inspections and external audits to ensure deadlines are met.


Handle Change Control processes and ensure on-time completion.


Manage Deviations and ensure effective corrective actions are implemented.


Supervise and ensure proper handling of market complaints, deviations, OOS, product recalls, and field alerts.


Make final decisions on the use or rejection of raw materials, packaging, and finished products; consult the Board of Directors for major decisions.


Audit suppliers of raw materials and primary packaging to ensure GMP compliance.


Review and approve Quality Agreements with suppliers and partners.


Lead process improvement initiatives, introduce new procedures, and oversee staff training.


Provide regular and ad hoc reports to senior management.


Ensure compliance with both local and international regulations.


Collaborate with Medical Affairs to handle adverse reaction complaints.


Coordinate product recalls when required.


Ensure all necessary licenses are maintained and valid.


Contribute to investment plans related to the Quality Division.


Ensure compliance with EHS (Environment, Health & Safety) policies, procedures, and international standards.


Directly manage the QA and QC departments.


Perform other tasks as assigned by the Board of Directors.