Quality Assurance Division Manager

Position : Quality Assurance Division Manager

Department : Quality Assurance

Reports to : President and Chief Executive Officer

The Quality Assurance Division Manager is responsible for overseeing the companys Quality Assurance and Quality Control functions. The role ensures that raw materials, packaging materials, in-process batches, and finished products meet client specifications and regulatory standards. The position also approves technical and quality system documents, manages compliance with cGMP and regulatory requirements, and leads the activities of QA / QC teams and support sections.

Key Responsibilities :

• Oversee QA and QC operations, including raw material, in-process, and finished product testing, packaging inspection, microbiological assays, stability studies, and compliance activities.
• Approve / reject materials and finished products based on established standards and specifications.
• Approve technical and quality system documents (e.g., validation protocols, deviations, change control, risk assessments, complaints, CAPA).
• Ensure compliance with cGMP, client requirements, and regulatory agencies (e.g., FDA, PICS, ISO standards).
• Lead audits and supplier qualification activities.
• Act as contact person for product recalls and client complaints, ensuring timely investigation and resolution.
• Supervise and evaluate the performance of QA / QC Managers, Technical Services, Validation, and other QA / QC teams.
• Provide direction on training programs related to cGMP and Quality Systems.
• Liaise with regulatory authorities, clients, and internal departments (Production, Engineering, Supply Chain, Technical Services, etc.).
• Recommend improvements in processes, systems, and equipment to ensure continuous compliance and quality excellence.

Supervisory Scope :

Qualification :

Packaging Material and Product Control