Operations Compliance Lead

Your mission Purpose of Job
As the Operations Systems Coordinator, you will be responsible for developing, managing, and improving systems that drive excellent performance across a balanced scorecard of safety, quality, service, cost, improvement, and people within the MeiraGTx Manufacturing organization.
Job Description Major Activities

• Responsible for compliance and delivery systems management within manufacturing, including but not limited to:
• GMP Document flow for batch release - BMRs, forms, logbooks, protocols, etc.
• MIAFs
• Tracking and completion of walkround and internal observations outcomes/actions
• Performance monitoring, trending, and KPI management for documentation and GMP compliance activities within Manufacturing
• Project management and delivery of improvements to manufacturing processes, procedures, and ways of working
• Support overall progress of internal investigations into manufacturing deviations and safety incidents, leading where appropriate
• Process document updates and revisions, e.g., SOPs, BMRs, WIs, etc.
• Ensure that own work and that of the team comply with GMP, Data Integrity, and Good Documentation Practice (GDP), in accordance with applicable procedures
• Ensure timely and GMP-compliant training for oneself and the team before tasks are undertaken
• Ensure GMP documentation is closed timely and in a ready-for-truth (RFT) state

Key Performance Indicators

• On-time delivery of manufacturing system outputs, e.g., BMR sign-off
• On-time closure of GMP compliance records within own responsibility, e.g., issues, CAPAs, change controls, audit/inspection actions
• Projects delivered as per schedule
• Quality performance of Manufacturing, including compliance KPIs and monitoring systems, kept up to date
• Self-development and training

Key Job Competencies

• Planning/Organizing: prioritizes work, uses time efficiently, sets goals
• Systems thinking: understands interrelationships and optimizes workflows
• Data-driven: proficient in data analysis to support improvements
• Problem Solving: identifies, analyzes, and resolves problems effectively
• Influencer: can influence diverse audiences to adopt better practices
• Change Management: plans and implements change effectively
• Leadership: demonstrates confidence in self and others
• Motivation: sets and achieves challenging goals, persists through obstacles
• Professionalism: tactful, responsible, respectful, reliable
• Quality Management: seeks continuous quality improvements
• Innovation: resourceful, suggests improvements, develops new ideas
• Oral Communication: clear speaking, active listening, effective presentation
• Written Communication: clear, concise, well-edited writing, effective data presentation

Qualifications

• University degree or HNC/HND in Science or Engineering
• Experience in pharmaceutical manufacturing
• Background in manufacturing operations and quality systems
• Collaborative team player with results-driven mindset
• Good understanding of GMP

Why us?