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Associate Director, Regional QA Lead
vor 3 Monaten
Key Responsibilities:
- In cooperation with International QA team, establish and maintain corporate quality objectives, actively promote an effective quality management system (QMS) in CEE region.
- Ensure documented system is in place to support GMP/GDP compliance management both internally and externally, with all manufacturers and third parties to whom activities are delegated.
- Maintain oversight of outsourced activities and associated quality technical agreements.
- Ensure close partnership with other QA teams within Vertex in relation to product launch (process development, alignment on roles & responsibilities etc) in ensuring clear QA representation within CEE affiliates.
- Act as the key liaison with Regional Business Partners in International Supply Chain and Commercial.
- Ensure alignment in QA activities and approach on projects between local RPs within CEE region and International/global QA. Assess impacts applicable.
- Act as the 'goto' QA Subject Matter Expert within CEE region.
- Lead regional QMS harmonisation initiatives and support business partners from the QA perspective.
- Ensure clear delegation of responsibilities that include Product Quality Reviews (PQRs), the retention of samples, mechanisms to ensure product supply and the management of falsified medicines.
- Maintain oversight of Named Patient Supply and Managed Access programs within the region.
- Ensure QA oversight in accordance with local requirements; ensure product procurement, storage and distribution are managed in accordance with GDP requirements.
- Build effective relationships with 3PL QA to manage issue resolution, process improvements, returns handling, KPI reporting and ensuring overall quality oversight.
- In collaboration with supply chain, ensure that supply chain maps are maintained for all distribution channels.
- Manage internal audits and support external audit scheduling, scope, and other qualification activities.
- Act as RP (FvP) on Establishment License on behalf of Vertex Switzerland in accordance with local requirements.
- Ensure Establishment License accurately reflects the current organisation, and vary licence as necessary
- Ensure that all the conditions of the Establishment license have been and are being compiled with and that the GxP guidelines are being followed.
- Act as QA single point of contact with Swiss Health Authorities. Ensure relevant stakeholder involvement and timely correspondence.
- Participate in quality escalation meetings providing input as an RP for Switzerland and where required, notify Health authorities of Quality Defects.
- Plan and host Regulatory inspections (Providing front and backroom inspection support and leading post inspection followup with responses and CAPAs
- Monitor, assess impact and communicate Regulatory Intelligence information
- Maintain knowledge of Good Distribution Practice
- Approval of applicable GxP documentation and SOPs and management of authorised activities
- Support product recall operations for Vertex CEE sites and where acting as RP (FvP)
- Ensure that customers and suppliers are approved
- Approve any subcontracting that may impact GDP
- Ensuring that selfinspections are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place.
- Decide on the final disposition of returned, rejected, recalled or falsified medicines, including the approval of returns to saleable stock.
- Release returned products to saleable stock for the Swiss market
- Assess Periodic Quality Reviews (PQRs)
- Play an active role in quality risk management and in periodic quality management review
- Ensure that any additional requirements imposed on certain products by national law are adhered to.
- Remain continuously contactable and available to attend the site as required
- Ensure procedures are in place outlining delegated activities to deputy RPs
- Managed and approve change controls, deviations and CAPA where required
Key Requirements:
- Relevant Degree
- Eligible to act as a Responsible Person for Switzerland (FvP)
- Able to leverage knowledge of organisational objectives, goals and mission to shape QA initiatives
- Takes riskbased approaches to create a variety of costeffective solutions that ensure that compliance and business requirements are optimized
- Broad health regulatory agency knowledge and experience across multiple GDP/GMP with current knowledge of industry trends and best practices for efficiency, compliance and effectiveness
- Strong leadership skills with the ability to lead a team to thrive in a fast paced, evolving environment
- Ability to recognize risks and issues impacting the budget, and develop recommendations for mitigation across scope of responsibility
- Excellent communication skills and a proven track record influencing/bu
