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 Validation and Qualification technical support and oversight for the manufacture and supply of Advanced Therapies Medicinal Products (Gene Therapy viral vectors).
This is a key role in;
The QA Validation will play a key role as part of the MGTX Ireland Project team providing hands on and “boots on the ground” QA technical support and oversight to Qualification and Validation activities of the Manufacturing facility and Laboratories, ensuring that processes and equipment are appropriately validated and qualified in accordance with applicable Irish, EU and FDA regulations and MeiraGTx QMS.
- Prepare and Maintenance of the Irish site validation plan for MeiraGTx
- Maintenance and archiving of Validation/Qualificaiton documentation
- Interface with other departments such as Engineering, Laboratories, Operations, Warehouse and Process Development to ensure that validation project plans are understood and in keeping with site objectives
- Clearly communicate and/or provide training in the required validation standard to both the Meira staff and contractors
- Review and approve validation, qualification protocols and reports
- Define and manage as system for project-related Deviations and Charge
- Maintain understanding of cGMP, Good Engineering Practices and guidance in relation to all aspects of validation across manufacturing, laboratories and facilities
- Support generation of Process and QC Equipment Installation, and Operational and Performance Qualifications, review and approve the Qualification protocols, discrepancies and reports for Quality
- Interface with external consultants and partners as directed by QA Validation and Materials Supply Manager, suppliers and contractors to ensure successful process and equipment validation. Provide QA support to data integrity compliance activities across the site. Write or assist in writing of MeiraGTx Policies, SOPs, work instructions and forms for validation requirements and other quality systems as required.
- Support Regulatory Inspections and third party audits.
- Ensure own work complies with GxP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable quality documents
- Ensure own training is undertaken in a timely and compliant manner before the task is undertaken
- To support the implementation “best practice” in validation for a new GMP Gene Therapy manufacturing facility ensuring validation of the processes and equipment meets applicable regulatory requirements
- To effectively guide the implementation of the Site Validation Master Plan, working with the engineering, operations and QC teams to oversee the commissioning; qualification and validation of the manufacturing facility and supporting activities
- Participate in risk assessments to develop process validation plans and protocols with Develeopment, Operations and QC staff
- Implement robust and ‘fit for purpose’ validation procedures ensuring the facility, equipment, and processes are validated, qualified and maintained to regulatory requirements
- All responsibilities are performed in a timely manner, escalating any and all issues to senior management as and when they occur
- Recommend improvement in validation management practices and documents
Key Job Competencies
- The individual must have an established track record in delivering robust and regulatory compliant Validation Plans and Protocols
- Extensive experience of GxP compliance requirements
- Able to Interact with other departments and personnel across the business both orally and in writing, demonstrating good interpersonal skills
- Can identify and escalate issues to line management, to ensure workload is prioritised, issues are highlighted to ensure business needs are met
- Able to respond flexibly and adapt to the needs of the department/wider business, demonstrating good organisational and time management skills List key competencies to fulfil role
Number of direct Reports – 0 (will change over time)
Financial authority – 0 (will change over time)
Job Background / Education
BSC in Science / Engineering
Languages – English
- Strong Quality Assurance background working in a Pharmaceutical or Biotech Production environment within sterile manufacturing
- Extensive experience with providing QA technical support and oversight to validation and qualification activities and with implementing the concepts, legislation, guidelines and requirements related to qualification and validation of sterile products, aseptic processes, equipment and systems, including Computer System Validation e.g. EU/FDA GMP guidelines, EU Annex 15, PIC/S & GAMP guidelines, EU Annex 11 & CFR Part 11 and ICH Q9
- Knowledge of cell culture-based manufacturing techniques and requirements and cellular and gene therapies
- Experience in using risk assessment tools including FMEA
- Ability to balance needs of the business with the needs of the Regulatory challenges
- Proven ability to work successfully in an ambitious, deadline-driven environment and handle multiple tasks simultaneously