Senior Quality Assurance Associate

About MeiraGTx

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.

Job Responsibilities

  • Support the training and coaching of the QA operations team

Job Background

  • 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

QA Team Leader -Quality Systems

About MeiraGTx

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

The QA Team Leader Quality Systems is responsible for providing QA support and oversight of MeiraGTx Quality Management System ensuring it is inspection ready and maintained in a state of control in compliance with applicable EU, UK and US GMP regulatory requirements.

Role is based in the UK, covering UK operations, providing support to Ireland, NL and USA sites as necessary.

Major Activities and Responsibilities:

  • Lead, Supervise, manage and train the QA Quality System team and continuously improve the local Quality system.
  • Provide training & support for Quality relevant systems in UK, NL, USA and Ireland.
  • Management and oversight of the document control process from creation to obsoleting including approval, management and archiving.
  • Generation, Review and approval of relevant GMP documentation
  • Assure compliance to EU and FDA GxP, MeiraGTx QMS and QA GMP operations, any other applicable regulations/standards
  • Act as SME for the Quality Management System and Documentation processes at regulatory and 3rd party audits
  • Manage the Quality Council meeting, co-ordinating presentation preparation, fronting the meeting, preparing the minutes and assigning/ tracking the actions.
  • Compile quarterly Quality metrics (KPI’s) for site
  • Provide KPI data for the Tier 3 meeting
  • Assure compliance to FDA and MHRA regulations and ensure retention of MIA(IMP) and MS Licenses
  • Ensure MeiraGTx remains inspection ready.
  • Lead “Level 1” meetings for QA team
  • Participate in Tier 2 meetings, representing the QA team and escalating to the QA Director-GMP as required
  • Oversight, review and management of Risks, Quality Events including incidents, deviation, investigations, change controls and CAPA ensuring they meet timelines.
  • Participate in the self-inspection process.
  • Coordinate preparation activities for Regulatory inspections and provide support to regulatory inspections as required by the QA Director-GMP.
  • Management of the Quality Systems Team and all aspects of the people process including hiring, on-boarding, mentoring, coaching, annual objective setting, performance management and employee development
  • Actively develop, mentor, train and instil a quality culture
  • Actively promote GMP within MeiraGTx
  • Ensure that own work and teams work complies with GMP, Data Integrity & 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 and teams training is undertaken in a timely and GMP compliant manner before the task is undertaken
  • Deputise for other QA Team leaders and the QA Director – GMP.
  • Perform other QA related tasks as assigned by the QA Director- GMP.

Key Job Competencies

  • Experience in leadership within QA
  • Experience of working within a Sterile/ Aseptic GMP manufacturing environment.
  • Understanding controlled processes.
  • Proficient in Microsoft Office and experience in database use and eQMS systems.
  • Planning/Organizing- prioritises and plans work activities; uses time efficiently; plans for additional resources; sets goals and objectives; organizes or schedules other people and their tasks; develops realistic action plans.
  • 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 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.
  • Ability to work in a fast-paced environment essential.

Job Responsibilities

  • Direct Reports: Manage/ supervise members of the Quality Systems team.

Job Background

  • Relevant Science based degree e.g. Chemistry, Biology, Pharmacy
  • Experience working in a GxP environment including a minimum 6 years’ experience in Compliance and Quality Assurance.
  • Working knowledge of the principles and guidelines for cGMP as out in UK “Orange Guide”, EU “Eudralex Volume 4”, U.S. “CFRs” and other relevant regulations/guidelines
  • Working and hands on experience with defining and implementing Quality Management Systems
  • Leadership and Management experience of successfully managing small teams is preferred
  • IT literate, experience managing and operating an electronic QMS
  • Excellent verbal and written communication skills
  • Excellent interpersonal skills with the ability to appropriately challenge others behaviours
  • Pragmatic / common sense approach to quality incidents