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Global Quality Assurance Specialist

1 week ago

Dublin, Dublin City, Ireland Tn Ireland Full time

At Uniphar, we are a rapidly expanding diversified healthcare services business with a global footprint and a proud heritage in Ireland.

We provide outsourced and specialised services to our clients, leveraging strong relationships with 200+ of the world's best known pharmaco-medical manufacturers across multiple geographies, enabled by cutting-edge digital technology and expert teams.

Our company is organised into three key divisions: Supply Chain & Retail, Commercial & Clinical (Med Tech / Pharma), and Product Access.

We have a workforce of close to 3,500 spread across Ireland, the UK, the Netherlands, the Nordics, Germany, and the USA, making us a trusted global partner to Pharma and MedTech manufacturers.

Culture at Uniphar We pride ourselves on being truly entrepreneurial, innovative, collaborative, with a strong problem-solving ethos.

We have built long-lasting working relationships with many of the world's largest Pharma and MedTech companies.

We believe 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 made possible 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 & Retail SC&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 the 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, while others have retained their original branding.

Our Irish business continues to grow steadily, and we are looking at opportunities to extend our successful Irish model to other markets.

Product Access Uniphar's strategy is to become the global leader in the provision of unlicensed and hard-to-find medicines to healthcare professionals and patients worldwide.

We partner directly with pharmaceutical manufacturers, designing and delivering global access programs that ensure appropriate patients have rapid access to new treatments and therapies when they need them most.

Our regulatory, digital, and global supply chain expertise ensures seamless access to vital medicines, providing an important bridge between manufacturers, healthcare professionals, and patients seeking access to medicines outside 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 Role EAP Quality Lead Within this role, you will be responsible for providing expertise and leadership for the compliant delivery of Uniphar's EAP programs.

You will ensure that all internal processes and client agreements adhere to relevant local and global regulatory guidance.

You will oversee the setup and management of external partners, including 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 support the global EAP Program team, consisting of program management, regulatory affairs, operations, and customer service, as well as digital platforms.

You will develop a strong working relationship with the site/country-level QA RP for each Uniphar location to support the delivery of a global integrated QA strategy for EAP within Uniphar Group.

Key Responsibilities:

  • Work closely with Director EAP programs to define the global QA strategy and implementation plans for the Global EAP team.
  • Drive the One Uniphar Quality Vision and work to support and engage cross-divisionally.
  • Contribute to the global governance framework for Uniphar performance in the delivery of EAP Programs and lead monthly and quarterly QA compliance and KPI review meetings.
  • Ensure that all EAP processes and procedures comply with GMP/GDP regulations and meet Uniphar standards for process development and implementation.
  • Develop and manage QMS specific to global EAP processes, ensuring the QMS is fit for purpose and make changes as necessary, approving SOPs and Quality System documents.
  • Work as part of the cross-functional team for each program setup and delivery and act as (or delegate) workstream lead for all quality-related outputs: Quality Technical Agreement, Audit, QA due diligence, SDEA agreement, etc.
  • Work 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.
  • Partner with critical contract clients across Uniphar to resolve compliance issues in clinical and commercial supply chains, interfacing with customer/partner quality organisations, and negotiating third-party contractor and supplier quality agreements.
  • Coordinate QA resources assigned to functional areas to meet goals and timings, prioritise activities with area management.
  • Develop and own global primary and secondary packaging and labelling processes and functions.
  • Work with individual Program Management teams to receive all documentation, and work with supply chain colleagues to set up each packaging and labelling project and oversee with outsourced partners to satisfactory completion of each campaign.
  • Support the EAP team on client interactions by acting as a SME on regulation surrounding packaging and labelling EAP medicines.
  • Develop partner 3PL quality KPIs.
  • Participate in cross-functional teams as Quality/Qualified Person representative.
  • Provide advice and direction to company departments on quality and regulatory issues.
  • Act 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 addressed and completed on schedule.
  • Authorise significant deviations to established, approved procedures, provides mentorship to assist co-workers with troubleshooting investigations and problem resolution.
  • Maintain safety and operational standards.
  • Manage the Quality Team responsible for EAP program management across all Uniphar contracting and sites and outsourced warehousing, distribution.

Key Requirements:

  • 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 Cryo storage environments.
  • 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.
  • Ability to analyse complex problems and identify solutions.
  • Strong communication and organisational 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 fulfill the role.