Senior Specialist, Quality Distribution

We are seeking applications for a Senior Specialist for QA Distribution for our Client who are a leading Biotech company based in Dublin.
 
In this role you will provide oversight and project management for Distribution operations led out of the Dublin facility with respect to the companies supply chain. The role will partner with key stakeholders including but not limited to; Shared Market Model Quality Team, Supply Chain Operations, Affiliate Quality and Commercial to provide direction and support in managing key project schedules within the company Quality System. As a member of the Country Quality team, the role may also provide commercial support to other business partners, supported by the group.
 
Why you should apply:

• Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.

What you will be doing:

• Ensure distribution compliance with applicable regulations, the WDA, Manufacturer’s Authorization and Intercompany Agreements as they pertain to GDP & performs GDP duties respectively.


• Provide Quality Distribution oversight for the Shared market model and associated change management activities.


• Responsible for the Quality oversight of cold chain activities in global markets in accordance with local and international requirements and company planning schedules; ensure products shipments are managed in accordance with GDP’s requirements.


• Provide Change Planning support and direction to GSC partners including but not limited to PfG distribution model changes, launches and key project schedules.


• Act as the Quality contact on records within the Quality System.


• Assess cold chain shipments and provides corresponding quality decision to support the distribution release of product.


• Review documentation including change controls, deviations, validation documentation, SOPs and specifications.


• Act as a Quality point of contact with distribution partners. Provide guidance, drive and monitor Quality issues related to cold chain and GDP to resolution within the organisation and with external parties.


• Ensure Quality Agreement with company distribution contractors and carriers are established and maintained.


• Support the readiness and execution of Health Authorities inspections.


• In collaboration with the Quality organization, weigh and communicate quality and compliance risks as appropriate


• Partner with local, regional and global operational groups to foster a proactive approach to Quality.


• Support the maintenance of the Quality Management System for Distribution.

 
What you need to apply:

• Provide Quality Distribution oversight for the Shared market model within the company and associated change management activities.


• Responsible for the Quality oversight of cold chain activities in global markets in accordance with local and international requirements and company planning schedules; ensure products shipments are managed in accordance with GDP’s requirements.


• Provide Change Planning support and direction to GSC partners including but not limited to PfG distribution model changes, launches and key project schedules.


• Act as the Quality contact on records within the Quality System.


• Assess cold chain shipments and provides corresponding quality decision to support the distribution release of product.


• Review documentation including change controls, deviations, validation documentation, SOPs and specifications.


• Act as a Quality point of contact with distribution partners. Provide guidance, drive and monitor Quality issues related to cold chain and GDP to resolution within the organisation and with external parties.


• Ensure Quality Agreement with  distribution contractors and carriers are established and maintained.


• Support the readiness and execution of Health Authorities inspections.


• In collaboration with the company Quality organization, weigh and communicate quality and compliance risks as appropriate


• Partner with local, regional and global operational groups to foster a proactive approach to Quality.


• Support the maintenance of the Quality Management System for Distribution.


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