Direct the manufacturing organization in the manufacturing of high quality products in strict adherence to applicable regulations, guidelines and industry standards.
Responsible for the training and development of all individuals associated with the manufacture of pharmaceuticals, as well as for the management of budgeted resources and protection of company assets. Ensure project coordination and completion in Maintenance, Engineering, Planning, Contract Manufacturing/Tech Svcs, EHS and Training departments.
Assume responsibility for the GMP/ISO 13485, health and safety awareness of all departments. This individual is the top divisional manufacturing manager.
1. Responsible for product supply.
2. Responsible for product and process quality, adherence to SOP’s and validated parameters.
3. Responsible for the departmental compliance of applicable ISO, FDA, OSHA and EPA regulations.
4. Responsible for proper staffing, training & development of all individuals associated within areas of responsibility. Support OpEx and EHS initiatives.
5. Responsible for the Quality improvement of RFT: batches, documents, quality systems, failure/scrap prevention and cost improvement.
6. Responsible for periodic assessment of product quality performance through Annual Product Review program.
7. Responsible for obtaining and providing feedback to the Quality Assurance Review Board on all policy matters.
8. Responsible for human and financial resources with the departments, including the periodic evaluations of performance against plans and standards.
9. Participates in the Material Evaluation Review Board to recommend strategies associated with product non-conformances.
10. Key role in technical transfer of new products and processes from R&D to Interdivisional and Contract Manufacturing operations.