Director, Quality Systems

Job description

Position Summary The OCNA Director Quality Systems will from the ground up build, implement, and maintain a robust Pharmaceutical Quality System (PQS) in compliance with cGMP, ICH Q10, and local regulatory standards (e.g., FDA, Health Canada, Texas Department of State Health Services) for a new pharmaceutical manufacturing facility. This role is responsible for the “hands on” development of the site quality organization, establishing Quality Control (QC) and Quality Assurance (QA) functions, and ensuring all facility, equipment, and production processes are validated and compliant before commercial launch. Essential Duties and Responsibilities: 1. QMS Implementation & Setup 2. Validation & Technology Transfer 3. Regulatory Inspection Readiness 4. Quality Operational Leadership 5. Culture & Team Development - Develop and implement a comprehensive Pharmaceutical Quality Management System (PQS) from scratch. Lead the design, development, project planning, deployment, maintenance, and improvements of the QMS system, procedures, and policies for the new facility. - Create and approve the facility Quality Manual, Quality Policies, and SOPs, ensuring alignment with global regulatory stand...