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QA Validation Manager

Permanent employee, Full-time · Shannon
Your mission
Leadership and mentoring of a team providing ongoing QA support pertaining to the validation requirements for all GxP processes, analytical methods, equipment, facilities, and computerised systems across MeiraGTx sites.

Remain up to date and act as a subject matter expert in relation to applicable EU and FDA regulations, ensuring that MeiraGTx validation policies and procedures remain compliant and best practice.

Allocation of team resource to ensure that all validation and technology transfer documentation is subject to QA review in a timely manner and in line with regulatory and business requirements.

Support QMS activities such as review of deviation investigations and impact assessment of change controls, where validation and computerised systems expertise is required.
Job Description
Major Activities
  • Adequately resource and provide QA support and oversight to activities related to validation, qualification and computerised systems activities, ensuring compliance with EU, UK and FDA GxP regulatory requirements, MeiraGTx QMS and any other applicable regulations/standards.
  • Maintaining an understanding of cGMP, GEP (Good Engineering Practice), computerised systems validation, and guidance in relation to all aspects of validation across manufacturing, laboratories and facilities.
  • Ensure that QA Validation team review and pre/ post approve Qualification protocols, discrepancies, and associated reports in a timely manner reporting any concerns to Senior QA Management.
  • Act as QA reviewer/ approver for MeiraGTx Policies, SOPs, work instructions and forms that govern the MeiraGTx validation and computerised systems requirements.
  • Develop and, where appropriate, deliver GxP training across the business regarding GxP, in particular in relation to validation and qualification (including computerised systems validation and data integrity).
  • Interface with other departments such as Engineering, Laboratories, Operations, Warehouse, IT, and Process Development to ensure that validation project plans are understood and in keeping with site objectives.
  • Represents the company as an SME for Validation, Data Integrity and Qualification compliance during regulatory inspections and partner audits, inclusive of support for the compilation of any required responses and other follow-up activities.
  • Support the execution of the site self-inspection and supplier audit programme where required when validation activities are within scope.
  • Management and mentorship of the QA Validation department, including all aspects of the people process such as hiring, on-boarding, mentoring, coaching, annual objective setting, performance management and employee development.
  • Responsible for the development, generation and monitoring of Key Performance Indicators for the QA Validation team and reporting to Quality Director.
  • Lead problem solving and remediation requirements for operational compliance systems.
  • Ensure area of responsibility is inspection ready and kept in compliance.
  • Responsible for ensuring that any GMP documentation e.g. (but not limited to) Issues, CAPAs, Change Controls, BMRs & audit/inspection actions, within own area of responsibility, are closed within date and in a ‘Right First Time’ state.
  • Ensure own and teams training is undertaken in a timely and compliant manner before any associated tasks are undertaken.
  • Ensure that own work and the teams work complies with GMP, Data Integrity & Good Documentation Practice (GDocP) and is undertaken in accordance with MeiraGTx’s QMS.
  • Deputising for Quality Director in Quality organisation when required.
Key Performance Indicators
  • In conjunction with the Validation function ensuring that company validation procedures are ‘fit for purpose’ and in line with regaulatory requirements.
  • Ensure that all GxP equipment, facilities, processes and analytical methods are appropriately qualified, and that they aer maintained in such a state throughout their lifecycle, informing Quality Director of any concerns in a timely manner.
  • All QA Validation team responsibilities are performed in a timely manner, escalating any and all issues to senior management as and when they occur.
Key Job Competencies
  • Experience in communicating with regulators during health authority inspections is desirable.
  • Can identify and escalate issues to line management, to ensure workload is prioritised, issues are highlighted to ensure business needs are met.
  • Approachable and professional manner, reacting well under pressure, accepting feedback and managing opinions of others.
  • Effective written communicator, able to deliver concise documentation, adapting writing style to audience as appropriate.
  • Ability to dissect problems and solutions to provide a variety of unique options in a comprehensive manner.
  • Ability to lead a cross-functional team, inspiring, motivating and challenging others as required.
  • Effectively manage changes in accordance with change control processes.
  • Logical, problem-solving manner, pragmatic, able to adapt to change.
People Responsibilities
  • Direct Reports: QA Validation Specialists
  • Manage and lead the QA validation team and all aspects of the people process including hiring, on-boarding, mentoring, coaching, annual objective setting, performance management and employee development.
  • Ensure staff development programmes are in place and implemented to assure competency (suitably qualified and experienced personnel) and support the achievement of objectives.
  • Support and encourage a “Quality Culture” and company “ACT” values.
  • Inspire and lead the team to meet department and site goals.
  • Responsible for ensuring that own work and that of the team complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable procedures.
  • Responsible for ensuring that own training and that of the team is undertaken in a timely and GMP compliant manner before the task is undertaken.
  • Responsible for ensuring that any GMP documentation e.g. (but not limited to) Issues, CAPAs, Change Controls, BMRs & audit/inspection actions, within own area of responsibility, is closed timely and in a RFT state.
Job Background
  • Educated to degree level in Human Health, Sciences or equivalent.
  • Minimum of 10 years experience working in a GxP environment, predominantly with regards to the execution or review of validation and computerised systems documentation.
  • Experience of line management.
  • Excellent practical Knowledge of GxP regulations and guidelines with regards to validation and qualification.
  • English language required.
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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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