We are seeking a Quality Assurance Compliance Specialist to join the Central Quality Systems and Compliance team. This role will interface globally with users across Global Operations, Country Operations, Research & Development, IT and Quality Operations to support execution and monitoring of the enterprise Quality Management System (QMS) governing Deviation, CAPA and Change Control.
• Assist global GxP business partners with the creation, review, approval and closure of deviations, investigations, CAPAs, change controls and associated quality risk assessments in compliance with internal and external requirements.
• Create and deliver QMS training (process and technical).
• Create and update QMS procedural documentation and work instructions.
• Extract and compile QMS data into reports for metrics and analysis.
• Develop and maintain strong relationships with global GxP stakeholders to establish communication channels for feedback and enhanced process understanding.
• Lead and participate in internal forums, for example, Change Control Review Board, CAPA Review Board and Communities of Practice.
• Completion of assigned projects and participation on global and local project teams, supporting delivery on time and in full.
• Proactively identify risks, trends & opportunities and support continuous improvement of global QMS processes and associated systems.
• Participate in inspection readiness activities and internal/external audits and inspections.
• 7 years’ + experience in Quality within the pharmaceutical industry.
• Prior experience in a Global QA role strongly preferred.
• Able to plan, prioritize and manage workload and manage to shift priorities to ensure commitments are met.
• Demonstrated critical thinking and problem-solving skills.
• Direct experience with development and approval of deviations, CAPAs and Change Controls.
• Knowledge of global GCP, GLP, GVP, GMP and GDP requirements for quality systems, medical devices and combination products.
• Excellent written and verbal communication skills.
• Direct experience with TrackWise desired.
• Bachelor’s degree in a technical or life sciences discipline (Chemistry, Biology, Biotechnology)