Overview

EU Quality Market Partner Jobs in Ireland at Biocon Biologics

Title: EU Quality Market Partner

Company: Biocon Biologics

Location: Ireland

At Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation, patient-centricity, and disruptive thinking. We are a multicultural global company where employees have a purpose and passion to work closely with partners and patients. We have a long-term commitment to bringing high-quality affordable biosimilars to patients all over the globe. We have proven end-to-end expertise from clone development, manufacturing, clinical development, and regulatory approvals to commercialization.


Role Purpos

eThe EU Quality Market Partner is responsible for supporting effective quality oversight of Biocon’s European market operations, with a focus on ensuring that affiliate, partner, third-party logistics and service provider activities are managed in compliance with applicable GxP, GDP, internal Quality Management System and Quality Technical Agreement requirements. The role provides practical quality support for market-facing activities, supply chain changes and post-release quality queries, while ensuring appropriate escalation of risks and maintenance of inspection-ready compliance standards

.Main Responsibilitie

  • sProvide quality oversight and support for EU market operations, including affiliate, partner, 3PL and service provider activities
  • .Support implementation and maintenance of GDP and GxP requirements across market-facing processes, including distribution, returns, recalls, redistribution and complaint-related activities
  • .Review and support Quality Technical Agreements and related quality documentation to ensure clear responsibilities and compliance expectations
  • .Provide quality input to supply chain changes, distribution arrangements and other changes affecting European market operations
  • .Support assessment, escalation and resolution of post-release quality queries raised by affiliates, partners, customers or service providers
  • .Monitor relevant local market regulatory and GDP requirements and support timely communication and implementation of required changes
  • .Manage or support quality records impacting market operations, including change controls, deviations, CAPAs and complaints, as applicable
  • .Work cross-functionally with Supply Chain, Commercial, Regulatory Affairs, Pharmacovigilance, Medical Information and Quality teams to ensure quality requirements are embedded in operational decision-making
  • .Support inspections, audits and service provider performance reviews where activities relate to affiliates, partners, 3PLs or European market quality processes
  • .Contribute to quality performance monitoring, KPI reporting, training and continuous improvement of EU market quality processes

.Minimum Experience and Qualification

  • sMinimum of 5 years’ experience in the pharmaceutical, biotechnology or life sciences industry, preferably within a quality, GxP, GDP, supply chain quality or market quality environment
  • .Demonstrated experience working with GDP and GxP systems is required as a minimum, including an ability to apply requirements in an operational and inspection-ready context
  • .Expected to operate with a high level of understanding of GxP and GDP systems, quality risk management, documentation standards, escalation pathways and regulated supply chain controls
  • .RP(i) and/or QP qualifications, or progress towards such qualifications, are desirable but not required

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