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
Act as the QA Documentation Controller for the business, ensuring that files stored and archived both within the electronic Quality Management System (eQMS; MasterControl) and outside of the eQMS are maintained appropriately according to relevant procedures.
Support validation of the MasterControl system to assure compliance across all sites; supporting project and upgrade re-qualification activities.
Provide first line support to end users for the MasterControl system, providing training as required.
Support the Quality Assurance team in other activities where requested.
- Perform daily administrative tasks for the MasterControl System, including, but not limited to:
- User Management
- Document Review, Approval & Release
- Reviewing Batch documentation
- Setup and maintain training courses and curriculum
- Workflow Management
- User Support
- eQMS and Document support during Regulatory, Competent authority and Third-Party audits.
- Issuance of Batch Manufacturing Records and Batch Numbers.
- Hard Copy Document Retention and Archiving.
- Organise and manage QA Document Control visibility and activities.
- Author and maintain procedural documents related to management of documents within the QMS
- Maintain documentation held externally from the QMS, including document issue, return and archiving as required
- Support QMS projects, including partaking in computer system validation activities where required
- Develop and deliver training related to the QMS and any other role related training as required
- Support Periodic System Reviews as required
- Provide Key Performance Indicator Reports for departments as required.
Key Performance Indicators
- The MasterControl document control system is maintained in a validated state
- General MasterControl administrative tasks are completed contemporaneously e.g. users are provided with access when applicable, documents are reviewed and approved in a timely manner to facilitate the progression of GxP activities
- All users are appropriately trained and supported when using the MasterControl Software.
- Documentation maintained outside of the MasterControl system is maintained in an easily retrievable state
- Any records overdue as escalated appropriately to facilitate progression
- Attend any required training as defined by line manager
- Metrics Reports are accurate and provided in a contemporaneous manner as required
Key Job Competencies
- Experience in working with electronic Quality Management Systems for document and process management
- Fully computer literate, proficient with standard software packages on an advanced level (such as Microsoft applications, specifically Excel, Word, PowerPoint) and adaptable to new software packages / web applications
- Experience in developing and delivering end user training, preferred system training
- Excellent interpersonal skills
- Good organisational and time management skills and able to demonstrate flexibility and adaptability
- Experience working with high volumes of documentation, electronic and paper
- Good attention to detail for data entry tasks and understanding of Good Documentation Practices
- A basic understanding of computer system validation in the pharmaceutical sector
- Experience and knowledge of working in a regulated environment, specifically with regards to record retention
- Knowledge of GCP and GMP with regards to QMS activities
- No direct reports
- Minimum of 3 years experience working in a GxP environment
- IT literate, experience managing and operating an electronic QMS
- English language required