Senior Quality Assurance Associate
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
Providing QA support and oversight at MeiraGTx
Ensuring QA regulatory compliance and product quality requirements are met at all times, as well as facilitating product release in a timely manner.
Coach and train the QA team and continuously improve the local Quality system and provide training & support for Quality relevant systems.
Major Activities and Responsibilities:
- Provide QA oversight to the manufacturing operation and supporting functions
- Management of the MeiraGTx Quality Management System
- Generation, Review and approval of relevant GMP documentation.
- Create QA Processes. Create Standard Operating Procedures, Policies and Training material.
- Maintain QA KPI metrics.
- Collaborate with Operational areas, supporting the Team Lead to manage the day-to-day QA Operations
- Review Batch documentation and support QA team review of Batch documentation. Ensuring timely and adequate release of GMP compliant product in accordance with Regulatory and site-specific authorisations.
- Manage and support QA team Facility walk rounds and QA support for all operational areas.
- Provide direct quality team support during customer and regulatory audits.
- Perform internal audits and inspections and audit write up.
- Quality Systems: Complete Reporting, reviewing, investigating, root cause analysis, assessing Quality risk assessments, Incidents, Deviations, CAPA’s, Change Controls and temperature excursions.
- Create and review Risk reporting and Mitigation.
- Support Document Management activities when required.
- Proactively initiate and support continuous improvement of the Quality Management System.
- Deliver compliance training to operational areas.
Key Job Competencies
- Experience of working within a sterile GMP manufacturing environment.
- Excellent understanding of Quality Management Systems.
- Proficient in Microsoft Office and experience in database use and eQMS systems.
- Excellent interpersonal skills
- Good organisational and time management skills and able to demonstrate flexibility and adaptability.
- Able to prioritise workload, decisive thinker able to work within agreed timescales.
- A high Level of attention to detail.
- Knowledge of GCP and GMP with regards to QMS activities
- Good team player and must also be able to work alone.
- Experience in Competent authority, Regulatory body inspections and audits.
- Support the training and coaching of the QA operations team
- 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