Associate Director - Quality/Ireland RP

Vertex Pharmaceuticals

Associate Director - Quality/Ireland RP

Vertex Pharmaceuticals

Ireland

Job Posting Description:

Operational Quality Associate Director & RP is a leader within International Quality organization who holds responsibility in ensuring quality compliance in two key areas: GMP activities that apply to Vertex Ireland as the Marketing Authorisation Holder and GDP principles and standards that Vertex Ireland must meet as the Wholesale Dealers Authorisation (WDA) holder in Ireland and other markets. This position holder has an oversight of the European distribution network and will lead quality improvement initiatives associated with outsourced 3PLs. Operational Quality Associate Director & RP ensures ongoing maintenance of the WDA license, leads regulatory inspections, and support International Quality in wider regional or global projects.

Key Responsibilities:

  • In cooperation with International QA team, establish and maintain corporate quality objectives, actively promote an effective quality management system (QMS) in Ireland;
  • Ensure documented system is in place to support GMP compliance management both internally and externally, with all manufacturers and third parties to whom activities are delegated;
  • Maintain oversight of Vertex Ireland outsourced activities and associated quality technical agreements;
  • Close collaboration with other QA teams within Vertex on managing internal audits and supporting external audit scheduling, scope and other qualification activities;
  • Act as QA single point of contact with Irish and other European Health Authorities. Ensure relevant stakeholder involvement and timely correspondence;
  • Participate in quality escalation meetings providing input as an RP for Ireland and where required, notify Health authorities of Quality Defects;
  • Ensure clear delegation of responsibilities that include Product Quality Reviews (PQRs), the retention of samples, mechanisms to ensure product supply and the management of falsified medicines;
  • Oversight of Named Patient Supply and Managed Access programs of EU and non-EU markets;
  • Ensure QA oversight of all GDP activities in accordance with local requirements; ensure product procurement, storage and distribution are managed in accordance with GDP requirements;
  • Build effective relationships with 3PL QA in order to manage issue resolution, process improvements, returns handling, KPI reporting and ensuring overall quality oversight;
  • Ensure robust process in place for bona fide checks for customers within Ireland, EU and 3rd countries;
  • In corporation with supply chain, ensure that Vertex Ireland supply chain maps are maintained for all distribution channels, including export countries;
  • Act as RP on Wholesaler Dealers Authorisation (WDA) on behalf of Vertex Pharmaceuticals (Ireland) Ltd in accordance with HPRA guide to Good Distribution Practice of Medicinal Products for Human Use and EU Guidelines of 5 Nov 2013 on Good Distribution Practice of Medicinal Products for Human Use. Work in partnership with deputy RP(s) to ensure that Vertex Ireland operations are in compliance with EU GDP:
    • Ensure WDA accurately reflects the current organisation, and vary license as necessary;
    • Ensure that all the conditions of the WDA have been and are being compiled with and that the GDP guidelines are being followed.
  • Plan and host Regulatory inspections (Providing front and backroom inspection support and leading post inspection follow-up with responses and CAPAs);
  • Monitor, assess impact and communicate Regulatory Intelligence information;
  • Maintain knowledge of EU Good Distribution Practice;
  • Approval of applicable GDP documentation and SOPs and management of authorised activities;
  • Coordinate product recall operations for Vertex sites where acting as RP;
  • Ensure that customers and suppliers are approved;
  • Approve any subcontracting that may impact GDP;
  • Ensuring that self-inspections are performed at appropriate regular intervals following a pre-arranged program and necessary corrective measures are put in place;
  • Decide on the final disposition of returned, rejected, recalled or falsified medicines, including the approval of returns to saleable stock;
  • Release returned products to saleable stock;
  • Ensure that any additional requirements imposed on certain products by national law are adhered to;
  • Remain continuously contactable and available to attend the site as required;
  • Ensure procedures are in place outlining delegated activities to deputy RPs;
  • Approve change controls impacting Ireland WDA, where required.

Key Requirements:

  • Ireland/EU RP on WDA license (Eligible to act as a Responsible Person in the European Union);
  • Able to leverage knowledge of organisational objectives, goals and mission to shape QA initiatives;
  • Takes risk-based approaches to create a variety of cost-effective solutions that ensure that compliance and business requirements are optimized;
  • Broad and deep global health regulatory agency knowledge and experience across multiple GDP/GMP with current knowledge of industry trends and best practices for efficiency, compliance and effectiveness;
  • Strong leadership skills with the ability to thrive a fast paced, evolving environment;
  • Ability to recognize risks and issues impacting the budget, and develop recommendations for mitigation across scope of responsibility;
  • Develop and apply creative solutions that meet demands of the function;
  • Excellent communication skills and a proven track record Influencing/building/promoting a culture of Quality and Excellence;
  • Work cross-functionally with all levels to foster exceptional collaboration;
  • Root Cause Analysis tools/methodology;
  • Sense of urgency- ability to act quickly/escalation process/transparency;
  • Attention to detail.

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© EuroJobsites 2022

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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