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:

• Direct supervision of QA/QC Managers, Technical Services, Validation, Quality Systems, Compliance, and other QA-related section heads.
• Indirect supervision of analysts, clerks, and technical staff.

Qualification:

• Bachelors Degree in Chemistry, Chemical Engineering, Pharmacy, or Industrial Pharmacy (licensed preferred).
• Minimum of 6 years managerial experience in Quality Assurance/Quality Control and/or Production, with specific exposure to:
  • Packaging Material and Product Control
  • Physical and Chemical Testing
  • Production/Manufacturing Operations
• Strong knowledge of cGMP, Quality Management Systems, regulatory requirements, and Good Laboratory Practices.
• Skilled in supplier audits, complaint management, product recall, validation, and CAPA management.
• Strong leadership, decision-making, and problem-solving abilities.
• Proficient in project management and computer applications.