GENERAL SUMMARY:

Associate Director, Responsible Person (Ireland) holds responsibility in ensuring quality compliance in Vertex Affiliate Ireland and GxP principles and standards that Vertex Ireland must meet as the Marketing Authorization Holder and Wholesale Distribution Authorisation holder. This position holder has an oversight of the distribution network and will lead quality strategic QA initiatives associated with it. This role holder also acts as the RP at Vertex Ireland ensuring ongoing maintenance of the license, leading regulatory inspections, and support International Quality in wider regional or global projects.

KNOWLEDGE AND SKILLS:

• Specialized depth of knowledge in GDP regulations, relevant to assigned region; broad knowledge of GMP and GVP regulations
• Depth of experience in GDP and GMP auditing
• Ability to collaborate cross functionally across all levels of the organization with strong communication skills and the ability to persuade others to adopt a new point of view
• Significant experience in designing, developing and delivering effective training
• Skilled at using sophisticated analytical thought to inform decision-making and achieve results.
• Highly skilled at time management, prioritization of own work, and planning/organization skills
• Demonstrates advanced ability to effectively communicate to local, international and global audiences
• Strong experience in managing/leading others to include performance management and career development
• Skilled in technical writing

EDUCATION AND EXPERIENCE:

• Bachelor’s degree in a scientific or allied health field (or equivalent degree)
• Requires relevant work experience, or the equivalent combination of education and experience
• Previously has worked as the nominated RP on a European WDA
  

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KEY DUTIES:

• Act as Responsible Person (RP) on the Wholesale Distribution Authorisation (WDA) held by Vertex Pharmaceuticals (Ireland) Ltd, ensuring in partnership with the Deputy RPs, that operations are compliant with HPRA guide to Good Distribution Practice of Medicinal Products for Human Use and EU Guidelines of 5 Nov 2013 on Good Distribution Practice of Medicinal Products for Human Use (2013/C 343/01). This role has the authority to take decisions with regard to their responsibilities.
• Support activities pertaining to the GMP-related responsibilities of Vertex Ireland as a Marketing Authorisation Holder (MAH) in compliance with Directive 2001/83/EC and Directive 2003/94/EC l aying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use. (Refer to * items below which may be duplicate to RP responsibilities).
• Provide QA leadership on projects related to distribution network improvements

KEY RESPONSIBILITIES:

• Ensuring that a quality management system is implemented and maintained
• Focusing on the management of authorised activities and the accuracy and quality of records
• Ensuring that initial and continuous training programmes are implemented and maintained
• Coordinating and promptly performing any recall operations for medicinal products
• Ensuring that relevant customer complaints are dealt with effectively
• Ensuring that suppliers and customers are approved
• Approving any subcontracted activities which may impact on GDP
• Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place
• Keeping appropriate records of any delegated duties
• Deciding on the final disposition of returned, rejected, recalled or falsified products
• Approving any returns to saleable stock
• Ensuring that any additional requirements imposed on certain products by national law are adhered to
• Remaining continuously contactable and available to attend the site as required
• Ensuring the WDA accurately reflects the current organisation, performing variations where necessary
• Performing review and approval of appropriate GxP documentation including procedures, work instructions, records and Quality Agreements
• Ensuring audits and other qualification activities are performed for all outsourced activities to ensure their compliance to the applicable GxP requirements
• Leading management review for Vertex Ireland
• Participation in quality risk management activities
• Participation in quality escalation meetings, providing input as an RP for Ireland and where required, notification to Health authorities of Quality Defects
• Managing and approving change controls, deviations and CAPA where required
• Planning and hosting Regulatory inspections (Providing front and backroom inspection support and leading post inspection follow-up with responses and CAPAs)
• Monitoring, assessing impact and communicating Regulatory Intelligence information
• Maintaining knowledge of EU Good Distribution Practice, applicable Good Manufacturing Practice and local GDP/GMP guidances
• supporting mechanisms to ensure supply of Medicinal products
• 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
• Acting as QA single point of contact with Irish and other European Health Authorities, ensuring relevant stakeholder involvement and timely correspondence
• Manage internal audits and support external audit scheduling, scope, and other qualification activities.
• Assessing and approval of applicable Periodic Quality Reviews (PQRs)