QA Specialist, Supplier Management

Permanent employee, Full-time · London

Your mission

Purpose of Job

  • Company lead and overall responsiblity for the design, maintenance and continuous improvement of a risk based GxP vendor assurance programme at MeiraGTx, ensuring it remains compliant and in line with current regulatory guidance/ expectations.
  • Responsible for defining and executing the on-boarding and qualification requirements for any newly proposed GxP supplier or service provider.
  • Ensuring that approved MeiraGTx GxP suppliers and service providers are subject to ongoing quality oversight and that quality audits/ assessments and supplier reviews are conducted as per schedule.
  • Ensuring that GxP supplier and service provider quality performance is assessed on an ongoing basis and that any issues are readily investigated or escalated as appropriate.
  • Ensuring that any changes to supplier or service providers scope of provision are appropriately assessed and any identified MeiraGTx actions readily implemented. 
  • Ensuring that (as applicable) agreements are in place, and kept up to date, with MeriaGTx suppliers and service providers to appropriately define quality expectations.

Job Description
 Major Activities
  • Review and approval of quality documentation pertaining to the lifecycle management of MeiraGTx material suppliers and service providers; i.e. supplier questionnaires, supplier risk assessments, supplier periodic assessments, supplier complaints, quality technical agreements, approved suppliers list, material impact assessments.
  • Authorship of core company policies, procedures and other supporting documentation pertaining to the MeiraGTx vendor and material assurance programmes.
  • Responsible for the compilation and coordination management of the GxP external audit schedule ensuring that supplier and service provider audits (on-site and desk-top) are completed as per due dates.
  • Escalation of any critical issues identified pertaining to MeiraGTx approved suppliers or service providers and provision of support for any required risk assessments or resolution management.
  • Support the generation, execution and periodic review of Quality Technical Agreements with approved MeiraGTx suppliers and service providers, ensuring that they remain accurate and within date.
  • When required support the development and delivering of training packages to applicable MeiraGTx functions pertaining to MeiraGTx supplier management policies and procedures.
  • Implementation/ generation of metrics in order to measure and monitor the key performance indicators established for the QA Supplier Management function and supporting systems.Include 8-12 main activities
  • Responsible for ensuring that any quality documentation owned by the QA Supplier Management function including (but not limited to) Issues, CAPAs, Change Controls, Audit/ Inspection Actions, are closed out as per due dates assigned.
  • Act as a the primary Subject Matter Expert (SME) for MeiraGTx supplier management processes during regulatory and partner audits/ inspections.
  • Act as an impact assessor for QA Supplier Management on MeiraGTx Change Controls and Issues when required.
  • Qualification and quality oversight of MeiraGTx approved third parties providing GxP services, reporting any issues in a timely manner to Senior QA Management.
  • Responsible for the ongoing quality oversight of MeiraGTx approved GxP suppliers and service providers ensuring that any supplier complaints are readily raised and followed through to closure in a timely manner.
  • Responsible for ensuring that any supplier change notifications are readily assessed in a timely manner by MeiraGTx core stakeholders and raised within the company PQS as appropriate
  •  Ensure own targets and objectives are readily established and effectively monitored.
  • ·Responsible for ensuring that own work adhere to GMP, data integrity and GDocP practice as per regulatory and MeiraGTx requirements.
  

Key Performance Indicators

  • Onboarding and qualification of new MeiraGTx GxP suppliers and service providers as per the timelines required by core company stakeholders.
  • Maintaining current GxP suppliers and service providers in a state of approval (if appropriate) via the timely execution of periodic qualification requirements as defined by MeiraGTx vendor assurance policies and procedures, inclusive of supplier audits and periodic assessments.
  • On time review and progression of supplier complaints and supplier change notifications in order to mitigate potential impact upon product quality and the supply chain.
  • On time closure of quality documentation including (but not limited to) Issues, CAPAs, Change Controls, Audit/ Inspection Actions. 
  • Ensures own and teams key performance indicators and objectives are readily tracked and completed on time, with any slippage reported to QA Associate Director – Compliance and External Quality in advance.
  

Key Job Competencies

  • An understanding of the regulatory guidance and industry standards pertaining to GxP vendor assurance/ supplier management programmes.List key competencies to fulfil role
  • Excellent communicator to both internal and external stakeholders, being able to deliver information in a concise and cordial manner.
  • Approachable and professional manner, reacting well under pressure, accepting feedback, and managing opinions of others.
  • Logical and able to problem solve in a consistent and calm manner in a time sensitive environment.
 

Job Background

  • Include details of education, language skills and experience required
  • Science based degree, e.g. BSc or MSc
  • Minimum 10 years experience working in a GxP regulated environment
  • Mininum 5 years working within a GxP vendor assurance function
  • Solid working knowledge of the principles and guidelines of GMP as set out in Eudralex Vol 4, US 21CFR Parts 210/211 and any other regulatory guidance relevant to job role responsibilities
  • Lead GMP auditor certification would be beneficial
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.

We are looking forward to hearing from you!
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