Senior QA Auditor, GCP/GLP
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
- This Senior Quality Auditor GCP/GLP role involves conducting and managing audit activities that serve to periodically assure compliance of the Clinical Operations, MeiraGTx offices and Vendors (eg Distributors, CROs, investigators) with company policies and procedures and applicable regulatory requirements.
- As a member of Quality Assurance ensure that audits are planned, conducted, followed up and managed in accordance with procedures as part of a Quality Management System (QMS) that allows MeiraGTx to achieve a high standard of compliance with regulatory guidance.
Major Activities and Responsibilities:
- Leads audit planning, conducting and reporting of MeiraGTx routine and non-routine audits of Clinical and non-Clinical Development activities, data, internal facilities and R&D processes in GxP to assure adherence to corporate policies, internal standards/requirements and compliance with applicable regulatory requirements. Non-routine audits include Due Diligence, for cause audits, cross-functional, complex/sensitive system/vendor audits as defined by the scope.
- This includes oversight of audits which are contracted out.
- In cooperation with the audited functions, advises and support in devising and executing remediation actions (CAPAs) to ensure compliance to regulatory and Global Quality expectations and requirements. Approves CAPAs and regularly reviews progress and continue to give ongoing support in all compliance
- Contributes in the continuous improvement and maintenance of a global GxP compliance platform for reporting, reviewing and trending Global Quality Audit KPIs
- Assists QA Management the development/enhancement of a risk based audit tool for prioritization of GxP audit activities
- Advises, guides and supports sites in the overall regulatory inspection management (preapproval inspections, general GxP inspections) covering inspection preparations, execution, preparation of responses to health authorities and inspection follow-up as well as for key customer
- Participates in regulatory inspections in core and supporting roles. Assists with the preparation and delivery of training materials. Advises and contributes to coaching. Completes training requirements in a timely manner to ensure inspection readiness at all times.
- Assists QA Management with the development/enhancement of a risk based tool for prioritization of GxP inspection readiness activities
- Ensure own work complies with GxP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable quality documents e.g. SOP’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
- A minimum of a bachelor’s degree is required
- 7-10 Years of Quality Assurance / Quality Systems experience in a GxP environment, clinical development, Medical Devices
- 5 Years of Quality auditing experience
- In depth knowledge with GCP/GLP guidance and regulations
- Fluent in English (verbal and writing)