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.
Purpose of Job
Undertake the duties and responsibilities of the Qualified Person as defined in Directives 2001/83/EC and 2001/20/EC.
Act as GMP Subject Matter Expert (SME) to facilitate site compliance with the company’s Quality Management system.
Ensure systems are identified and in place to maintain compliance with current established GxP standards.
Support senior QA leadership through QP decision making to drive continuous improvement and compliance.
Major Activities and Responsibilities
- Ensure batches are manufactured and tested to GMP and in line with the CTA/IND and PSF
- Review completed batch records and complete batch dispositions
- Develop and own the batch release process
- Provide QA oversight, technical QA expertise and leadership across all aspects of GMP Operations from Manufacturing, Tech Transfer through Warehouse activities, Engineering, Quality Control, Supply Chain and Operations support
- Identify, communicate, and escalate quality and compliance risks. Provide direction for and participate in timely resolution, acting always with an appropriate sense of urgency.
- Attend and participate in the Quality Management Review meetings
- Ensure that complaints, deviations, and any significant quality incidents are thoroughly reviewed and closed out in a timely manner
- Ensure changes are appropriately managed
- Approval of procedures and policies
- Work as part of the MeiraGTx team to undertake continuous improvement of business quality systems
- Advise and participate in projects from a quality assurance perspective
- Keep up to date with regulatory changes and developments, aiding the transition into company SOPs and processes
- Assist with regulatory inspections providing SME support. Assist in the remediation of regulatory findings and closure of deficiencies.
- Support self-inspection process, providing coaching to self-inspection auditors and review of the outcomes of audits
- Strong interpersonal skills must have the ability to establish and maintain effective working relationships with internal and external peers and stakeholders
- Experience of leading/participation in EU and US competent authority inspections