Quality Manager (12-month contract)

Position
Purpose

The Quality Manager, reporting to the Quality Operations team for the EU & MEA region, is responsible for ensuring effective quality oversight and compliance with GxP requirements across iNova’s operations and partners’ network.

• Act as the Responsible Person (RP) under iNova Pharmaceuticals (Ireland) Limited 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)
• Provide end‑to‑end quality oversight of the iNova product portfolio, ensuring that required quality activities, assessments, and ongoing monitoring are effectively performed by approved warehousing and distribution partners and GxP service providers.
• Partner with warehousing, distribution partners, and GxP service providers to support and drive the implementation of continuous improvement initiatives.
• Collaborate cross‑functionally with Commercial, Supply Chain, Regulatory Affairs, Medical Affairs, and other stakeholders to strengthen a collaborative quality culture and promote a quality‑driven mindset across the organisation.
• Provide GxP quality operations guidance and support to iNova commercial entities to ensure compliance with applicable market regulations and support the achievement of business objectives, including:
  • Quality oversight of Contract/External Manufacturers (CMO/EMO), third‑party logistics providers, and distributors, ensuring appropriate quality processes are performed without unnecessary duplication by iNova.
  • Oversight activities that may include site inspections, audits, and routine governance meetings to confirm ongoing compliance with quality standards and service level agreements.
• Author, review, and/or approve quality documentation in accordance with documentation and record‑keeping requirements, including but not limited to:
  • SOPs, Work Instructions, forms
  • Product Quality Reviews (PQRs)
  • Deviations and quality investigation reports
• Maintain and manage the Quality Management System (QMS), including Change Control, Deviations and CAPA, Customer Complaints, and associated quality performance metrics.
• Support due diligence activities for new external manufacturers and new products, and support external and internal audits as required.
• Support the maintenance, effectiveness, and continual improvement of the quality system.
• Ensure the planning and execution of self‑inspections, and support audits conducted by external parties, including Health Authorities and customers.

Key Accountabilities
&
Performance
Indicators

1. Product Quality Management

• 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
• Manage the product release process to a < 3-day timeframe from batch receipt, while minimizing recall incidences or critical product quality issues
• 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
• Manage and oversee individual deviations, NCR & 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
• Collaborate with functions to ensure complaints are managed and resolved according to compliance with regulations and SOPs within the required timeframes
• Support internal and external audits activities to ensure audit findings are resolved within the agreed timeframes

2.      Collaboration and stakeholder management

• 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.
• Collaborates closely with the wider iNova organization to ensure quality activities are completed and in compliance with regulation requirements and SOPs.
• Takes initiative to support other functions in quality operations activities where relevant.
• Functions as an integral part of the Quality Ops team.
• Coordinate with local/regional Regulatory teams and ensure EMOs or Distributors readiness for Health Authority inspections and proactively manage
  interactions and commitments with stakeholders and/or Health Authorities as required.

Key Working Relationships

Internal

Commercial, Supply Chain and Planning; Sales and marketing, Regulatory Affairs, Technical operations

External

Warehouse and Distributors, Repackers, Service Providers, Marketing Authorisation Holders and Regulatory agencies