Operations Compliance Lead

MeiraGTx; London; On-site; GBP 40,000 - 60,000; Full time

Job summary

A leading company in the pharmaceutical sector is seeking an Operations Systems Coordinator in London. The successful candidate will focus on managing systems that enhance safety, quality, and efficiency in manufacturing processes. If you have a degree in Science or Engineering and a background in manufacturing operations, this is an excellent opportunity for growth and innovation.

Qualifications

• Experience in pharmaceutical manufacturing required.
• Background in operations and quality systems is essential.
• Collaborative team player with results-driven mindset.

Responsibilities

• Manage compliance and systems within manufacturing.
• Oversee GMP documentation and training.
• Lead improvement projects for manufacturing processes.

Skills

Planning/Organizing

Data-driven

Problem Solving

Collaboration

Quality Management

Education

University degree or HNC/HND in Science or Engineering

Job description

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?