[ref. n7375917] Quality Assurance Division Manager - Santa Rosa

Reports to: President and Chief Executive Officer

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.