Quality Manager (12-month contract)

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  "inferred_at": "2026-06-06T10:20:06.525Z",
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    "jobOpeningName": "Quality Manager (12-month contract)",
    "departmentLabel": "Quality",
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    "location": {
      "city": "Dublin",
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      "postalCode": "D02 YX28",
      "addressCountry": "Ireland"
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    "datePosted": "2026-04-23",
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    "description": "<p><span style=\"font-weight: bold\">Position </span><br><span style=\"font-weight: bold\">Purpose</span></p>\n\n\n\n\n<p>The <span style=\"font-weight: bold\">Quality Manager</span>, reporting to the <span style=\"font-weight: bold\">Quality Operations team for the EU &amp; MEA region</span>, is responsible for ensuring effective quality oversight and compliance with <span style=\"font-weight: bold\">GxP</span> requirements across iNova’s operations and partners’ network.</p>\n<ul>\n<li>Act as the <span style=\"font-weight: bold\">Responsible Person (RP)</span> under <span style=\"font-weight: bold\">iNova Pharmaceuticals (Ireland) Limited</span> for medicinal products covered by the Wholesale Distribution Authorisation (WDA), ensuring full compliance with the latest EU Guidelines on Good Distribution Practices (GDP) of Medicinal Products for Human Use (2013/C 68/01)</li>\n<li><span style=\"font-size: 12pt\">Provide </span><span style=\"font-weight: bold\">end‑to‑end quality oversight</span><span style=\"font-size: 12pt\"> of the iNova product portfolio, ensuring that required quality activities, assessments, and ongoing monitoring are effectively performed by approved </span><span style=\"font-weight: bold\">warehousing and distribution partners</span><span style=\"font-size: 12pt\"> and </span><span style=\"font-weight: bold\">GxP service providers</span><span style=\"font-size: 12pt\">.</span></li>\n<li>Partner with warehousing, distribution partners, and GxP service providers to support and drive the <span style=\"font-weight: bold\">implementation of continuous improvement initiatives</span><span style=\"font-size: 12pt\">.</span></li>\n<li>Collaborate cross‑functionally with <span style=\"font-weight: bold\">Commercial, Supply Chain, Regulatory Affairs, Medical Affairs</span><span style=\"font-size: 12pt\">, and other stakeholders to strengthen a </span><span style=\"font-weight: bold\">collaborative quality culture</span><span style=\"font-size: 12pt\"> and promote a quality‑driven mindset across the organisation.</span></li>\n<li>Provide <span style=\"font-weight: bold\">GxP quality operations guidance and support</span><span style=\"font-size: 12pt\"> to iNova commercial entities to ensure compliance with applicable market regulations and support the achievement of business objectives, including:</span>\n<ul>\n<li>Quality oversight of <span style=\"font-weight: bold\">Contract/External Manufacturers (CMO/EMO)</span><span style=\"font-size: 12pt\">, </span><span style=\"font-weight: bold\">third‑party logistics providers</span><span style=\"font-size: 12pt\">, and </span><span style=\"font-weight: bold\">distributors</span><span style=\"font-size: 12pt\">, ensuring appropriate quality processes are performed without unnecessary duplication by iNova.</span></li>\n<li><span style=\"font-size: 12pt\">Oversight activities that may include </span><span style=\"font-weight: bold\">site inspections, audits, and routine governance meetings</span><span style=\"font-size: 12pt\"> to confirm ongoing compliance with quality standards and service level agreements.</span></li>\n</ul>\n</li>\n<li>Author, review, and/or approve <span style=\"font-weight: bold\">quality documentation</span><span style=\"font-size: 12pt\"> in accordance with documentation and record‑keeping requirements, including but not limited to:</span>\n<ul>\n<li>SOPs, Work Instructions, forms</li>\n<li>Product Quality Reviews (PQRs)</li>\n<li>Deviations and quality investigation reports</li>\n</ul>\n</li>\n<li>Maintain and manage the <span style=\"font-weight: bold\">Quality Management System (QMS)</span>, including Change Control, Deviations and CAPA, Customer Complaints, and associated <span style=\"font-weight: bold\">quality performance metrics</span>.</li>\n<li><span style=\"font-size: 12pt\">Support </span><span style=\"font-weight: bold\">due diligence activities</span><span style=\"font-size: 12pt\"> for new external manufacturers and new products, and </span>support external and internal audits as required.</li>\n<li>Support the <span style=\"font-weight: bold\">maintenance, effectiveness, and continual improvement</span><span style=\"font-size: 12pt\"> of the quality system.</span></li>\n<li>Ensure the planning and execution of <span style=\"font-weight: bold\">self‑inspections</span><span style=\"font-size: 12pt\">, and support audits conducted by external parties, including </span><span style=\"font-weight: bold\">Health Authorities and customers</span><span style=\"font-size: 12pt\">.</span></li>\n</ul>\n<p> </p>\n\n\n\n\n\n\n\n<p><br></p>\n\n\n\n<p><br><br></p>\n\n\n\n<p><span style=\"font-weight: bold\">Key Accountabilities </span><br><span style=\"font-weight: bold\">&amp; </span><br><span style=\"font-weight: bold\">Performance </span><br><span style=\"font-weight: bold\">Indicators</span></p>\n\n\n\n\n<ol>\n<li><span style=\"font-weight: bold\">Product Quality Management</span></li>\n</ol>\n<ul>\n<li>Work in collaboration with contract / external manufacturer, and internal functions to ensure EMO partners conduct the required quality oversight, through OOS/NCR/ Deviation and CAPA, Change Control and routine stability testing monitoring, on time and in compliance to GMP and applicable standards</li>\n<li><span style=\"font-size: 12pt\">Manage the product release process to a &lt; 3-day timeframe from batch receipt, while minimizing recall incidences or critical product quality issues</span></li>\n<li>Manage and oversee change control processes, and action on individual change controls within the defined target dates and in compliance to GMP and iNova SOPs</li>\n<li>Manage and oversee individual deviations, NCR &amp; CAPA processes, and action on them in compliance with GMP and iNova SOPs, and in alignment with timeframes of iNova’s business needs, to minimize recall incidences or critical product quality issues</li>\n<li>Collaborate with functions to ensure complaints are managed and resolved according to compliance with regulations and SOPs within the required timeframes</li>\n<li>Support internal and external audits activities to ensure audit findings are resolved within the agreed timeframes</li>\n</ul>\n<p> </p>\n\n\n\n\n<p><span style=\"font-weight: bold\">2.      C</span><span style=\"font-weight: bold\">ollaboration and stakeholder management</span></p>\n<ul>\n<li>Ensure timely and effective escalation of quality incidents, with robust analysis to assess potential impact on supply, compliance, patient safety, or iNova’s reputation. Where appropriate, management of incidents via the Critical Action Committee (CAC) process with impacted stakeholders and communication to MAH and/or Distrbutors as required.</li>\n<li>Collaborates closely with the wider iNova organization to ensure quality activities are completed and in compliance with regulation requirements and SOPs.</li>\n<li>Takes initiative to support other functions in quality operations activities where relevant.</li>\n<li>Functions as an integral part of the Quality Ops team.</li>\n<li>Coordinate with local/regional Regulatory teams and ensure EMOs or Distributors readiness for Health Authority inspections and proactively manage<br><span style=\"font-size: 12pt\">interactions and </span>commitments with stakeholders and/or Health Authorities as required.</li>\n</ul>\n\n\n\n<p>  </p>\n<p> </p>\n\n\n\n<p><span style=\"font-weight: bold\">Key Working Relationships</span></p>\n\n\n\n\n<p>Internal</p>\n\n\n<p>Commercial, Supply Chain and Planning; Sales and marketing, Regulatory Affairs, Technical operations</p>\n\n\n\n\n<p>External</p>\n\n\n<p>Warehouse and Distributors, Repackers, Service Providers, Marketing Authorisation Holders and Regulatory agencies</p>\n\n\n",
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