QA Specialist, Supplier Management

Purpose of Job

• Company lead and overall responsibility 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.

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