Our client is a mid-sized pharmaceutical company that is preparing for commercialization and they are seeking and experienced QA leader to provide expertise and leadership in implementing and managing a quality system management function for clinical and commercial products.
This position is responsible for development, management and continuous improvement of Quality Systems to ensure its products and processes are compliant to regulatory, functional area and business partner or customer requirements. You will partner with all areas of the business to understand their needs and elevate potential issues to management and drive continuous improvement efforts.
• Provide expertise on implementation and maintenance of a Quality Management System (QMS), both electronic and paper based, including but not limited to document control, training, change management and quality event management
• Develop, implement and manage an integrated viewpoint aligned with department management for the Quality System
• Create, implement and manage key performance and Quality indicators (KPI and KQI) and metrics/dashboards for the QMS to be shared with management
• Provide guidance for computer system validation plans and summaries in accordance with the SDLC and Part 11/Annex 11 and review/approve all computer system validation deliverables
• Facilitate continuous improvement initiatives designed to increase efficiencies
• Manage the inspection process for regulatory and partner audits and responses to audits
• Ensure effective and timely Quality support of commitments to corporate timelines, milestones and regulatory requirements
• Partner with functional teams to identify and implement optimized system designs
• Manage process improvements for Quality Systems
• Actively influence and participate on Quality initiatives from a strategic compliance perspective
• Direct, manage, provide guidance and develop staff
• Maintain the corporate Quality Manual
• Review, comment, and approve Quality agreements with partners and vendors as applicable.
• Responsible for budget in functional area.
Qualified candidates will have a BS degree or higher and 15+ years’ experience in Pharmaceutical, Biotechnology or related industry in a quality role with increasing levels of responsibility. Must have leadership experience including leadership of direct reports.
• Ability to interpret external regulatory/compliance documents and internal metrics to propose appropriate mitigation
• Working knowledge of software solutions for QMS
• Extensive knowledge and understanding of global requirements for cGXP and quality systems for clinical and commercial