QA Senior Specialist
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
To provide QA support and oversight for the Irish manufacturing site during facility design, build and qualification, for the manufacture and supply of clinical and commercial Advanced Therapies Medicinal Products (Gene Therapy viral vectors).
The QA Senior Specialist will play a key role in the implementation and improvement of the local Quality Management System. The QA Senior Specialist will provide hands on and Quality on the Shop Floor compliance support and oversight to activities of the Manufacturing facility and Laboratories, ensuring regulatory compliance and product quality requirements are met at all times.
- Provide QA support and oversight to the Irish operations team ensuring compliance with EU, Irish and FDA cGxP regulatory requirements, MeiraGTx QMS and any other applicable regulations/standards Include 8-12 main activities
- QA review and approval of quality documentation generated in Irish operations e.g., including but not limited to Deviations, CAPAs, change controls, logbooks, SOPs, risk assessments, OOO/OOT, temperature logs, etc).
- Support a “Quality on the Shop Floor” culture through facility walk rounds to maintain a high level of compliance and QA oversight by working closely together with operations ensuring proactive approach to identify potential issues and minimise impact.
- Generate and prepare quality documents e.g., SOP’s and controlled documents e.g., SOPs and Training Material.
- Ensure compliant and adequate systems are in place to monitor investigations, CAPAs, audits and Quality Review Boards.
- Support the preparation, execution and follow up on regulatory inspections.
- Perform (plan, execute, follow up) self-inspections in a timely manner as per plan
- Perform external audits of key suppliers and service providers where required.
- Provide QA review for the eQMS system documents
- Aid in the management and proactively initiate and support continuous improvement of the Quality Management System.
- Deliver GxP compliance training to operational areas
- Ensure own work complies with GMP, Data integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable quality documents e.g., SOP’s, BMR’s, Protocols, Guidance’s etc.
- Ensure own training in undertaken in a timely and GMP compliant manner before the task is undertaken
- Ensure own KPI’s, plans, targets and objectives are effectively tracked, monitored and achieved in accordance with timelines. Aid in maintaining QA Operations Team KPIs.
Key Job Competencies
- 10 years of experience of working in a GMP regulated environment, biotechnology or related manufacturing is preferred
- Experience in the operation and improvement of all aspects of a local QMS including investigations, change controls and CAPAs
- Positive attitude with demonstrated flexibility to adapt to the needs of the department/wider business, demonstrating good organisational and time management skills
- Can identify and escalate issues to line management, to ensure workload is prioritised, issues are highlighted to ensure business needs are met
- Experienced in performing internal and/or external audits
- Proficient in Microsoft Office and experience in database use and eQMS systems
- Excellent interpersonal skills
- Able to prioritise workload, decisive thinker able to work within agreed timescales
- A high level of attention to detail
- Good team player and must also be able to work alone
- Experience in the management of Competent authority, Regulatory body inspections and audits
- No direct reports
- Experience working in a GxP environment including a minimum 5 years’ experience in Compliance and Quality Assurance
- IT literate, experience managing and operating an electronic QMS
- Excellent verbal and written communication skills