Operations Compliance Lead

Purpose of Job

As the Operations systems coordinator, you will be responsible for developing, mangaging  and improving systems that drive excellent performance across a balanced scorecard of safety, quality, service, cost, improvement and people within the MeiraGTx Manufacturing organisation.

Major Activities

• Responsible for compliance and delivery systems management  within manufacturing including but not limited to:
  1. GMP Document  flow for batch release  -BMRs, forms,  Logbooks, Protocols etc.
  2. MIAFs 
• Tracking and completion of walkround and internal observations outcomes/actions
• Responsible for performance monitoring, trending and KPI management  for documentation and GMP compliance activities within Manufacturing
• Project management and delivery of improvements to the manufacturing process, procedures, and ways of working
• Support overall progress of internal investigations into manufacturing deviations and safety incidents and lead where appropriate.
• Process document updates and  revisions e.g. SOP, BMRs WI etc.
• Responsible for ensuring that own work and that of the team complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable procedures
• Responsible for ensuring that own training and that of the team is undertaken in a timely and GMP compliant manner before the task is undertaken
• Responsible for ensuring that any GMP documentation, is closed timely and in a RFT state

Key Performance Indicators

• On time delivery of manufacturing system outputs e.g. BMR sign sign off 
• On time closure of  GMP compliance records within own area of responsibility e.g. (but not limited to) Issues, CAPAs, Change Controls & audit/inspection actions, 
• Projects delivered to agreed schedules 
• Quality performance of Manufacturing including compliance KPI  and monitoring systems kept up to date
• Self development and training 

 

Key Job Competencies

• Planning/Organizing - prioritizes and plans work activities; uses time efficiently; plans for additional resources; sets goals and objectives
• Systems thinking – understands interrelationships between activities and systems and optimises ways of working to deliver the best overall results
• Data driven – highly proficient in acquiring, manipulating and analysing data to support performance improvement
• Problem Solving - Identifies and resolves problems in a timely manner; able to gather and analyze information; develops alternative solutions; works well in group problem solving situations
• Influencer – understands how to influence people with diverse backgrounds at different levels of the organisation to adopt better approaches consistently
• Change management – capable of planning and executing change in a way that people understand and adopt into their daily work
• Leadership - exhibits confidence in self and others
• Motivation - sets and achieves challenging goals; demonstrates persistence and overcomes obstacles; measures self against standard of excellence; 
• Professionalism - approaches others in a tactful manner; reacts well under pressure; treats others with respect and consideration regardless of their status or position; accepts responsibility for own actions; follows through on commitments.
• Quality Management - looks for ways to improve and promote quality; demonstrates accuracy and thoroughness.
• Innovation - meets challenges with resourcefulness; generates suggestions for improving work; develops innovative approaches and ideas.
• Oral Communication - speaks clearly; listens and gets clarification; responds well to questions; demonstrates good presentation skills; participates effectively in meetings.
• Written Communication - writes clearly and informatively; edits work for spelling and grammar; varies writing style to meet needs; presents numerical data effectively; able to read and interpret written information.

 
Qualifications

• University degree or HNC/HND in Science or Engineering
• Experience in pharmaceutical product manufacture
• Background in manufacturing operations and quality systems
• Ability to work collaboratively with colleagues and peers from a range of functions and backgrounds in a results-driven, team-oriented environment
• Good understanding of GMP

MeiraGTx is a clinical-stage gene therapy company focused on developing potentially curative treatments for patients living with serious diseases. We currently have six programs in clinical development including three ocular indications, a salivary gland condition, and a Parkinson’s disease program. Our initial focus on diseases of the eye, salivary gland and central nervous system is based on the significant unmet medical need coupled with the high potential gene therapy has to provide meaningful clinical benefit in these areas. With headquarters in New York and London, our global footprint provides us the opportunity to partner with leading institutions around the world, allowing us to deepen our understanding of diseases and their progression.

Our team was built with deep expertise in gene therapy development, allowing us to efficiently advance our programs from preclinical to clinical development. Our core capabilities in viral vector design and optimization and gene therapy manufacturing give us a differentiated approach to developing gene therapies. Additionally, we are developing proprietary technology to potentially enable innovative gene therapy treatments whose expression can be turned on and off with an easily administered small molecule. We believe temporal control of gene therapy products has the potential to transform the gene therapy landscape.

Our state-of-the-art manufacturing facility, completed in early 2018, was designed to meet global regulatory requirements, including the current good manufacturing practices (cGMP) required by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK and the U.S. Food and Drug Administration (FDA). The 29,000-square foot facility has the flexibility and capacity to produce sufficient product for all our clinical trials and will scale to commercial capacity.