Associate Director, Regional QA Lead

vor 3 Wochen

Zug, Schweiz Vertex Pharmaceuticals Vollzeit

Job Description

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 ‘go-to’ 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. Work in partnership with deputy RP(s) to ensure that Vertex Switzerland operations are compliant 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 follow-up 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 self-inspections are performed at appropriate regular intervals following a pre-arranged 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 risk-based approaches to create a variety of cost-effective 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

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