MeiraGTx
Senior QA Associate
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Your Mission
Provide experienced QA support and oversight to MeiraGTx operations. Ensure 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 other functions and continuously improve the local Quality system and provide training & support for Quality relevant systems.
Job Description
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 and Review QA Processes. Create/review 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, OOS, Change Controls and temperature excursions.
- Support Document Management activities when required.
- Proactively initiate and support continuous improvement of the Quality Management System.
- Deliver compliance training to operational areas.
- Provide guidance and assistance to quality related issues in Operational areas and to External third parties.
- Deputise for the QA Team Leader – Operations when required.
- Proactive individual, able to step in without being asked. Identifies upcoming activities or tasks and works on completion without the need to be asked.
- Collaboration and stakeholder management.
- Adaptability ad resilience.
- Supports innovation by challenging outdated practices and encouraging better ways of working.
- Always asks and understands the “why” and is capable of explaining this to others. Does not automatically accept the status quo.
- Finds better ways for completing existing activities/processes saving time or effort while remaining compliant.
- Data driven decision making. Able to check reliability of sources, identify gaps, inconsistencies or misleading information.
- Demonstrates critical thinking and logical reasoning.
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Key Job Competencies and Behaviours
- Minimum 5 years experience of working within a sterile GMP manufacturing environment.
- Excellent understanding of Quality Management Systems.
- Demonstrate very good understanding of the purpose of the regulation requirements in terms of how they translate to product quality and patient safety.
- Proficient in Microsoft Office and experience in database use and eQMS systems.
- Excellent interpersonal skills. Role model for professional behaviours, respectful relationships, positive and constructive communication.
- Capable of demonstrating structured thinking, data gathering and analysis for informed decisions.
- Good organisational and time management skills and able to demonstrate flexibility and adaptability. Capable of consistent on-time delivery of their individual tasks and responsibilities. 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 independently.
- Strong experience in Regulatory inspections and Client audits.
Job Background
- Experience working in a Sterile manufacturing GMP 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.
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Why Us?
About Us
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.
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