Commercial QA Manager Nordics

• Ensuring process compliance with our client’s Global Quality System, EMA regulations and guidelines and requirements set by local regulatory agencies in Denmark, Sweden and Norway.

• Ensuring that the Quality Management System (QMS) is implemented and maintained in adherence to our client’s Global QMS.

• Managing all Quality Assurance activities for our client’s existing and new product portfolio in the Nordic Market.

• Representing Global Quality Assurance in cross-functional teams and providing strategic Quality Assurance and GDP Compliance input to support the Nordic Business Affiliate operating the markets in the region regarding our client’s product portfolio.

• Providing country specific information on national cultural attitudes and our client’s reputation among customers and patients to our client’s global headquarters so that such information can be incorporated into our client’s global business strategies.

• Providing support as needed to the Nordic Business Affiliate for local and regional in-licensing and out-licensing activities.

• Providing support to the Global Quality Assurance-External Supply Quality team (ESQ) to manage any third-party processes and activities in the Nordic Region.

• Collaborating with the Commercial Quality Manager UK/IE on continuously improving and operating the Quality System and Quality Manual for the Nordic & UK/IE Cluster.

• Managing and processing incidents, deviations, CAPAs and change control in the Nordic region.

• Manage the Product Quality Complaints System including escalation of issues to the Product Incident/Recall Committee.

• Promptly executing recalls based on the instructions and recommendations of the Product Incident/Recall Committee in the Nordic region. Hereunder, coordinating with Global functions and notifying national regulatory agencies.

• Participating in the local Crisis Management Team acting as the cGMP/GDP Subject Matter Expert potentially escalating critical issues to the Product Incident/Recall Committee.

• Promoting continuous improvement of our client’s local and global quality procedures by analyzing Quality KPIs and derive measures for possible process and product improvements.

• Sharing best practices from the Nordic Affiliate with our client’s global network.

• Advising the GM of Client Nordics and employees of cGMP/GDP risks that will have an impact on the business operations in the Nordic region.

Good Distribution Practice (GDP) Responsible

• Maintaining Wholesale Distribution Licenses for our client's nordic affiliates.

• Executing regular cGMP/GDP training for personnel whose activities impact on product quality.

• Defining an annual schedule and performing, in cooperation with Global Functions, self-inspections of business processes which have an impact on GDP processes and product quality and identity.

• Documenting incidents and deviations that impact the quality and identity of medical products/devices and GDP processes and records.

• Assembling Product Incident/Recall Committee and implement, manage and audit CAPAs where such are required to correct any critical issues based on approved plans and timelines with the affected business process owners.

• Ensuring that product complaints are evaluated, processed and investigated. Hereunder reviewing and archiving all subsequent investigation reports and distributing these to necessary external stakeholders in compliance with our client’s procedures and local regulatory requirements.

• Verifying and reviewing audit and qualification documentation of all suppliers, transportation and distribution services, and customers to ensure that these have been audited, licensed, qualified and approved by our client’s Global Quality Assuance, ESQ and local regulatory agencies.

• Reviewing, approving and documenting any subcontracted activities which may impact on product quality and identity and GDP processes.

• Inspecting and making final disposition of returned, rejected, recalled or counterfeit products. Hereunder, approving any returned products to saleable stock.

• Following requirements set by local regulatory agencies regarding medicinal product import and disposition in Denmark, Norway and Sweden and executing processes outlined in our client's SOP's.