Position Summary:
As a key member of the Quality Systems team, this individual will serve as a strategic and tactical quality professional managing systems and compliance to support GxP operations and Quality functions. This individual will be a key member of the Quality Organization to drive maturity, compliance, and ease of use of the Quality Management System. We are looking for a self-driven, resourceful Senior Quality Systems Manager with up-to-date knowledge, and demonstrated experience driving and sustaining improvement to the Quality Management System to ensure compliance to all applicable standards.
Duties and responsibilities
• Provide QA Oversight to the initiation of Change Controls.
• Review activities performed for change controls to ensure all necessary activities have been appropriately executed prior to approving closure of the change.
• Vendor Quality Management
• Customer Quality Management
• Documentation System
• Change Control System
• Works with other departments to proactively build quality into the processes and systems.
• Oversight of the GMP Documentation System and training program.
• Manage and coordinate timely and effective completion of routine documentation and change control tasks through the planning and assigning of responsibilities.
• Schedule and to prioritize tasks involving Documentation systems to promote efficient use of time.
• Prepare and enhance Standard Operating Procedures related to responsible Quality System.
• Review and approval of reports/data generated by Quality Systems Associates
• Generate, gather and analyze data to support specified Quality System.
• Automates job functions to achieve efficiency improvements.
• Identifies and implements key process improvements to enhance systems, gain site efficiencies and elevate GMP requirements.
• Additional duties as assigned
Experience:
• BS with 5+ years in quality systems and operations
• Knowledge of ICH, GLP, cGMP requirements
• Any exposure to GXP regulations would be a plus.
• Broad experience in quality systems within a large stage pharmaceutical setting.