The Distribution QA Director will play a central role in shaping and strengthening the group’s distribution quality organization. Working in close collaboration with the Head of QA this position will define strategic objectives and deliver on targets related to distribution QA activities.Beyond ensuring compliance, the Distribution QA Director will coordinate with the network of Responsible Persons fostering alignment, expertise, and efficiency across the organization. The role will also be instrumental in contributing in the harmonization of distribution processes, providing strategic insights into supply chain and logistics practices to support the ongoing transformation of the group’s wholesaling activities.Finally, the QA Director will act as Responsible Person (RP) and Responsible Person for Import (RPi) in the UK, a regulatory requirement essential to the continuity and compliance of our operations as a pharmaceutical wholesaler.What You Will DoIn addition to the regulatory accountabilities of the Responsible Person/Responsible Person for Import (RP/RPi), the QA Director will provide strong managerial leadership to engage, align, and inspire the QA/Responsible Persons network and ensure a culture of quality and compliance across the organization. The scope of responsibility includes not only UK distribution activities but also oversight of export distribution operations. Key duties include, but are not limited to:Ensuring the provisions of the Wholesale Dealer’s Authorisations (WDA) are fully observed.Maintaining compliance with MHRA regulations, EU GDP Guidelines (2013/C343/01), Human Medicines Regulations 2012 (as amended), and the current Rules and Guidance for Pharmaceutical Distributors (UK).Acting as RPi for the release of imported products into the UK market, in accordance with Annex 16Liaising with the MHRA regarding inspections, audits, and compliance issues, while preparing for and participating in such inspections.Regulatory Compliance & OversightEstablishing, implementing, and maintaining effective Quality distribution processes System (QMS), with clearly defined systems, procedures, and responsibilities, ensuring permanent inspection-readiness.To maintain GxP compliance regulations to ensure that the applicable standards and regulations are adhered at all times. This includes following of standard operating procedures and approved written documentation.Driving harmonization and continuous improvement of distribution quality processes and SOPs in close collaboration with stakeholders.Overseeing audits within his/her field of responsibility, approving audit plans, and ensuring timely completion of internal and external audits related to distribution process.Ensuring adequate records are maintained to demonstrate ongoing GDP compliance.Quality Management & Process LeadershipSupervising and ensuring compliance of both UK and export distribution activities.Approving export orders and monitoring related compliance requirements.Providing strategic input to strengthen efficiency, risk management, and compliance in global distribution flows.Deciding on the fate of returned, quarantined, counterfeit, falsified, or recalled goods, including timely communication with Competent Authorities.Overseeing mock recalls, compliance checks, and product portfolio controls to safeguard quality and patient safety.Approving GDP-related change controls, deviations, and complaint reports, ensuring trends are analysed and acted upon.Supplier, Partner & Stakeholder ManagementEnsuring suppliers, distributors, and customers are qualified and subject to annual bona fide checks.Preparing, reviewing, and approving Quality Technical Agreements with distribution partners.Providing GDP input for Product Quality Reviews (PQRs)Leadership, Training & CultureProviding managerial guidance and leadership to the QA/RP network, fostering collaboration and consistency across the organization.Promoting a strong quality culture, encouraging adherence to the highest compliance standards, and ensuring that all staff are trained in GDP and fully understand their responsibilities.Acting as a key point of reference within the company, bringing expertise, vision, and influence to strengthen supply chain and logistics processes while maintaining compliance.What We DoEssential Pharma is a global pharmaceutical company working to make a difference for patients in niche populations.Everything at Essential Pharma is driven by the fact that every patient matters. We are focussed on developing and delivering medicines for patients in small, underserved or rare disease populations. Our team of 70+ people has an entrepreneurial spirit, challenging convention and working creatively to deliver results. Our headquarters are in Surrey, UK, and we have offices in Malta, France, Spain and Switzerland.What You Will BringMaster’s degree in pharmacy (e.g., Pharmacy, Chemistry, Biology) or Engineering degreeEligible to a RP/RPi positionSignificant experience as Responsible Person / Responsible Person for ImportationDemonstrated experience supporting or managing quality system processes (e.g., Deviation, CAPA, Change Control)Expertise on EU GDP guidelines, MHRA expectations and Supply Chain processFamiliarity with electronic Quality Management Systems such as Veeva.Previous exposure to similar pharmaceutical business models and third-party oversight desirableStrong attention to detail and documentation accuracyEffective problem-solving skills and critical thinking mindsetAble to work independently with minimal supervisionCollaborative, strongly team-oriented approachAdditional European language is a plus (German, Spanish, French)Strong communication skills, both written and verbalResults-driven with a continuous improvement mindset.What We OfferWe understand that productivity requires balance, so we offer office-based contracts and allow flexibility on locations of work when required and appropriate.£150 towards your home officePension – you contribute 5% and we offer 5%.Life Insurance – lump sum (tax free) death benefit of 4 x basic salary.Enhanced family leave25 days annual leaveDiscretionary annual performance bonus #J-18808-Ljbffr