A unique opportunity has arisen to join a leading global speciality pharmaceutical company that focusses on acquiring prescription medicines across a broad range of therapeutic areas in international markets and optimising these established medicines. Headquartered here in Ireland, this organisation is currently undergoing significant expansion and therefore a new requirement in the organisation has arisen for a Head of Quality & Responsible Person which will offer the successful candidate the ability to lead all Quality activities for the business business globally with a primary focus on the US market.

The Position

• Maintain the Quality Management System and quality objectives under applicable GMP and GDP regulations including but not limited to oversight of deviations, complaints, product quality review, change controls, CAPA's, PQR's/aPQR's, procedures, training, customer management, supplier management.
• Actively promote an effective quality management system (QMS).
• Ensure documented system is in place to support GMP and GDP compliance management both internally and externally, with all partners, manufacturers and third parties to whom activities are delegated.
• Maintain oversight of outsourced activities and associated quality technical agreements.
• Ensure customers and suppliers are adequately qualified, and re-qualified as required, in line with local SOPs.
• Manage and complete batch records review and release for the US market, as required.
• Ensure QA oversight of all GDP activities in accordance with local requirements; ensure product procurement, storage and distribution are managed in accordance with GDP requirements.
• Provide QA support and diligence of new product acquisitions.
• Managing internal audit(s) and external audits, audit scheduling, scope and other qualification activities.
• Management and oversight of the product stability program.
• In corporation with supply chain, ensure that supply chain maps are maintained for all distribution channels, including export countries.
• Act as RP on Wholesaler Dealers Authorisation (WDA) on behalf of the organisation in accordance 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.
• Ensure WDA and ASR accurately reflects the current organisation, and vary license as necessary.
• Plan and host Regulatory inspections and leading post inspection follow-up with responses and CAPAs.
• Monitor, assess impact and communicate Regulatory Intelligence information.
• Approval of applicable GDP documentation and SOPs and management of authorised activities.
• Coordinate product recall operations for the business where acting as RP, where required.
• 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.
• 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, where required.

The Person

• Science qualification or similar with 8+ years experience in a high level quality leadership position.
• 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 optimised.
• Broad and deep global 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 thrive a fast paced, evolving environment.
• Ability to recognise risks and issues impacting the budget, and develop recommendations for mitigation across scope of responsibility.
• Develop and apply creative solutions that meet demands of the function.
• Excellent communication skills and a proven track record Influencing/building/promoting a culture of Quality and Excellence.
• Work cross-functionally with all levels to foster exceptional collaboration.
• Root cause analysis tools/methodology.
• Sense of urgency-ability to act quickly/escalation process/transparency.

To discover more about this opportunity, apply now or contact Shane Browne at HRM Search Partners on +353 1 6321865 for a confidential discussion.