Compliance Lead, Clinical
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
As part of the QA Clinical team (UK), the purpose of this role is to support the development and maintenance of the Quality Management System related to Clinical operations ensuring it is implemented, inspection ready and maintained in a state of control in compliance with applicable national and international GxP rules and regulations.
Major Activities and Responsibilities:
- Provide expertise and oversight for GCP, ensuring that the quality and compliance of Development and Clinical Trails Studies, products and programs (Phase I-IV) meet with regulatory requirements
- To assist with development of the MeiraGTx QMS for Clinical Operations for all GCP related activities to ensure compliance with GxP regulations is maintained through implementation of appropriate processes, risk assessments, gap assessments and training
- In collaboration with the MeiraGTx Clinical Operations department drive the implementation of the GCP phase appropriate Quality Management System to achieve a high level of quality and compliance for development Research Studies, products and programs
- To streamline and improve Clinical quality processes
- Support, plan and host self-inspections and regulatory inspections
- Responsible for systems and processes around internal retention and archiving for Quality Assurance and Clinical Operations documentation and effectively manage the strategic operation of third party Archiving Facility and processes
- Provide QA GCP support and oversight to the UK Clinical Operation team, ensuring compliance with EU, UK and FDA cGCP regulatory requirements, MeiraGTx QMS and any other applicable regulations/standards
- QA review and approval of GCP quality documentation generate by UK Clinical Operations team e.g. but not limited to Deviations, CAPAs, Change Controls, SOPs, risk assessments etc.
- Generate and prepare quality documents e.g. SOP’s and controlled documents
- Work with the MeiraGTx Clinical Operations team and GCP QA Audit Team to provide and support for quality and compliance in relation to GCP matters
- Support, plan and host internal/external audits and regulatory inspections in coordination with the Clinical Operations team and QA Audit Team
- Proactively coordinate and oversee responses from of Audit Observations, GCP quality investigations as needed e.g. deviations, serious breaches, and assist with the CAPA Development (where necessary this could be in conjunction with nominated third parties)
- Responsible for providing oversight and follow up of CAPAs from audits and Quality Issues in GCP and maintain KPIs for all GCP activities in conjunction with Clinical Operations personnel to monitor and ensure compliance on an ongoing basis
- Management reporting – Ensure timely escalation and effective communication of all relevant GCP quality matters within the organization to QA Management
- Ensure own work complies with all GxP, 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 is undertaken in a timely and GxP 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
Key Job Competencies
- Good working knowledge and understanding of pharmaceutical Quality Assurance and GCP experience within a clinical trails and operations environment.
- Good understanding and working knowledge of preparing SOP’s and with reviewing and approval of devaitions, CAPA, Change Controls etc.
- 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 all GxP 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
- Degree in Life Sciences or similar related field
- Proven experience (at least 5 years) in the pharmaceutical industry in a relevant field such as GCP Compliance quality assurance, regulatory drug safety, clinical development or a directly related area
- Extensive experience in clinical research & GCP
- A working knowledge of other GxP areas is also desired