EAP Quality Lead

Job title:

EAP Quality Lead

Company

Allcare Pharmacy

Job description

Who we areUniphar Group is a rapidly expanding diversified healthcare services business with a global footprint and a proud heritage in Ireland. Since Uniphar became a publicly listed company in 2019, the Group has grown organically and through a series of strategic acquisitions, which continue to strengthen Uniphar’s international reach.Uniphar provides outsourced and specialised services to its clients, leveraging the strong relationships with 200+ of the world’s best known pharmaco-medical manufacturers across multiple geographies, enabled by our cutting-edge digital technology and our expert teams. Uniphar is organised into three key divisions: Supply Chain & Retail, Commercial & Clinical (Med Tech / Pharma) and Product Access.With a workforce of close to 3,500 spread across Ireland, United Kingdom, the Netherlands, the Nordics, Germany and the USA, Uniphar is a trusted global partner to Pharma and MedTech manufacturers, working to improve patient access to medicines and treatments around the world.Culture at UnipharWe pride ourselves in being truly entrepreneurial, innovative, collaborative, with a strong problem-solving ethos. We have built working relationships which span decades with many of the world’s largest Pharma and MedTech companies. We believe that this is because we know how to build a relationship of trust with our partners – we put our customers and their patients at the heart of what we do and treat them with integrity and respect. Everything Uniphar does is enabled by our people. As we continue to grow domestically and internationally, we become more diverse. This rich diversity fuels our business and enriches our culture.Supply Chain & RetailSC&R is Uniphar’s largest division and a leader in the Irish pharmaceutical wholesale, pre-wholesale and retail pharmacy markets. The division runs, owns or supports through symbol groups more than 400 of Ireland’s 1850+ community pharmacies and is primary supplier to another 500. Acquisitions in this division have been primarily of retail pharmacy chains, some of which have been rebranded to the Uniphar symbol groups of Allcare Pharmacy and Life Pharmacy, others which have retained their original branding, eg Hickey’s Pharmacies. Our Irish business continues to grow steadily and we are looking at opportunities to extend our successful Irish model to other markets.Product AccessUniphar’s strategy is to become the global leader in the provision of unlicensed and hard to find medicines to healthcare professionals and patients around the world. Partnering directly with pharmaceutical manufacturers, Uniphar designs and delivers global access programmes that ensure appropriate patients have rapid access to new treatments and therapies at the time they need them most. Uniphar’s regulatory, digital and global supply chain expertise ensures seamless access to vital medicines, providing an important bridge between manufacturers, healthcare professionals and patients to access medicines outside of traditional clinical and commercial channels. With the acquisition of specialist service providers in the US and Europe, Product Access continues to expand its global footprint to meet the needs of our global customer base.The RoleEAP Quality LeadWithin this role you will be responsible for providing expertise and leadership for the compliant delivery of Uniphar’s EAP programs.
You will be responsible to ensuring that all internal processes and client agreements adhere to the relevant local and global regulatory guidance. You will also be responsible to oversee the set-up and management of external partners; global wholesaler networks, outsourced warehousing and distribution, GMP facilities and any other GXP relevant vendors or suppliers.
You will work as part of the global Quality team to directly support the global EAP Program team, consisting of Program management, regulatory affairs, Operations and customer service and digital platforms. Developing a strong working relationship with the site / country level QA RP for each Uniphar location to support in the delivery of a global integrated QA strategy for EAP within Uniphar group. .Key Outcomes

• Works closely with Director EAP programs to define the global QA strategy and implementation plans for the Global EAP team
• Drive the One Uniphar Quality Visions and work to support and engage cross divisionally
• Responsible for contributing to the global governance framework for Uniphar performance in delivery of EAP Programs and leads on the monthly and quarterly QA compliance and KPI review meetings
• Responsible to ensure that all EAP processes and procedures comply with GMP / GDP regulations and meet Uniphar standards for process development and implementation.
• Development and management of QMS specific to global EAP processes, ensure the QMS is fit for purpose, making changes as necessary approving SOPs and Quality System documents.
• Works as part of the cross functional team for each program set-up and delivery and acts as (or delegates) workstream lead for all quality related outputs: Quality Technical Agreement, Audit, QA due diligence, SDEA agreement etc.
• Works closely with global supply chain colleagues to ensure that subcontracted facilities utilised within EAP Programs (both Uniphar and external vendors) are set-up, managed and deliver as per each SLA and within GDP and GMP regulations
• Partnering with critical contract clients across Uniphar to resolve compliance issues in clinical and commercial supply chains, interfacing with customer/partner quality organizations, and negotiating third party contractor and supplier quality agreements
• Coordinating QA resources assigned to functional area to meet goals and timings, prioritization of activities with area management
• Development and ownership of global primary and secondary packaging and labelling processes and functions
• Works with individual Program Management teams to receive all documentation, and works with supply chain colleagues to set-up each packaging and labelling project and oversee with outsourced partners to satisfactory completion of each campaign
• Supporting the EAP team on client interactions by acting as a SME on the regulation surrounding packaging and labelling EAP medicines.
• Development of partner 3PL quality KPIs
• Participating in cross functional teams as Quality/Qualified Person representative
• Providing advice and direction to company departments on quality and regulatory issues
• Acting as an auditor on behalf of Uniphar for GMP/ GDP activities
• Involved in aspects of Regulatory Agency interactions and preparation as related to site inspections, and ensuring regulatory observations are adequately addresses and completed on schedule
• Authorising significant deviations to established, approved procedures, provides mentorship to assist co-workers with troubleshooting investigations and problem resolution
• Ensuring safety and operational standards are maintained
• Management of the Quality Team responsible for EAP program management across all Uniphar contracting and sites and outsourced warehousing, distribution and

Key Skills & Experience

• 5 years’ work experience acting as Qualified Person, named on the Manufacturing and Importation Authorisation (MIA) license and or IMP
• Previous experience in the area of Biologics / Gene Therapy and or Cyro storage environments
• You have expert knowledge of 2001/83/EC and Annex 16, EudraLex, Volume 4, EU Guidelines for Good Manufacturing Practice for medicinal products for human and veterinary use
• Ability to work on their own initiative and within teams.
• Be able to analyse complex problems and identify solutions.
• Strong communication and organizational skills.
• Leadership skills.
• Excellent ability to deliver results, with strong interpersonal and influencing skills.
• Ability to build relationships internally and externally.
• Trained auditor.
• Available to travel if required to fulfil role.

Expected salary

Location

Ireland

Job date

Fri, 07 Mar 2025 02:17:01 GMT

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