Company Background

Uniphar Group PLC is one of two full line pharmaceutical wholesalers operating in the Irish market. With a turnover expected to be in excess of €1.2billion for 2015, Uniphar is one of Ireland’s most successful indigenous companies, managed and run from our headquarters in Citywest, Dublin. The full line wholesaler is the middle man between the Manufacturers and the Pharmacy, who receive in bulk and breaks down and delivers the medicine in average units of 2 across 12,000 products twice daily.

Active right across the pharmaceutical/health supply chain, the Uniphar Group has wholesale depots located in Dublin, Cork, Limerick and Sligo, the company has now built the strongest wholesale depot structure in the Irish market. Our Citywest Distribution Centre (CDC) is a €65M state of the art warehousing and distribution facility and is one of the most technologically advanced of its kind in Europe. This ensures that we offer an excellent distribution service to meet the needs of manufacturers, community pharmacy, hospital pharmacy and veterinary surgery across the country.

Set up 40 years ago by community pharmacists to allow them to control their own supply chain, the roots of the Uniphar Group remain in community pharmacy and ownership is still held largely by community pharmacists. Today Uniphar Group employs approximately 550 people.

In 2013, Uniphar acquired Cahill May Roberts, one of its main competitors, and since then has undertaken a serious investment in IT and infrastructure, including SAP, while integrating the two businesses. Entrepreneurial and fast moving, the company is expected to list on the stock exchange in the next few years.

In 2015 Uniphar continues to grow and has recently acquired Star medical a UK business who provides a full outsourcing and resourcing solution that delivers sales, marketing, medical and clinical people for Pharma, Medical Devices & Technology, Clinical Research and Healthcare Communications businesses; Star’s tailored services include dedicated teams, vacancy management, direct to headcount recruitment, consultancy and master vendor. Uniphar also acquired Point of Care Point who is Ireland’s leading community specialist healthcare provider. It provides services in the community that allow patients to be cared for in a more comfortable and less costly alternative to hospitalisation.

People & Culture

At the core of Uniphar Group are its people and our employees are the driving force of the business. Uniphar is passionate about hiring and developing high-potential individuals and giving them fast track, long-term careers.

The company hires more than anything on cultural fit and potential to grow within the business. It is a fast moving business in an industry that is going through a lot of change – this means our people have to be adaptable, quick thinking and focused on results.

In order to succeed in Uniphar you will be smart, down to earth, highly commercial and driven. You will need to be flexible in how you think and a strong problem solver. You will also need to be a good leader, able to get the best from your own team and also to work cross functionally and interact effectively with people at all levels of the business.

Role and Responsibilities

Serve as the designated Responsible Person, ensuring full compliance with ProLuca WDA requirements and all related GxP and Medical Device activities within the On Demand Ireland business unit.
Act as DRP on Uniphar Wholesale WDA
Ensure all tasks are executed in alignment with Uniphar Group’s policies and procedures.
Lead and coordinate regulatory and client inspections as necessary.
Manage and guide the Quality team to achieve strategic and operational objectives.
Design, implement, and maintain a Quality Management System (QMS) that meets the compliance standards of a Marketing Authorisation Holder (MAH).
Ensure adherence to quality standards as defined by the QMS.
Train and support staff in new quality initiatives, promoting understanding and consistent implementation across the site.
Maintain and update regulatory standards and procedures in line with applicable regulations, guidelines, and specifications.
Identify opportunities for system improvements or technical issues, collaborating with technical teams to develop and implement effective solutions.
Oversee outsourced activities for the On Demand business, ensuring robust compliance processes in Pharmacovigilance (PV), Regulatory Affairs, and Advertising, with clearly defined MAH responsibilities in the QMS.
Act as a Subject Matter Expert (SME) for the management of Exempt Medicinal Products within the On Demand business.
Evaluate requirements and provide feedback on completeness, risk areas, and potential impacts on quality compliance.
Collaborate with the wider On Demand Quality and Management Teams to identify and implement process improvements.
Contribute to the development of high-quality systems that meet documented specifications, compliance standards, and business objectives.
Lead cross-functional meetings to triage and resolve quality issues.
Foster strong relationships with internal and external stakeholders, promoting a culture of continuous improvement.
Prepare and maintain weekly and monthly reports/KPIs summarizing key activities and performance metrics.
Engage in ongoing professional development and support team learning to stay current with evolving regulations and ensure timely implementation.
Manage third-party providers and processes related to outsourced GMP activities.
Undertake additional projects or activities as assigned by the Group Quality Director.

QUALIFICATION, EXPERIENCE & SKILLS REQUIRED

3–5 years of professional experience in a regulated environment (GDP, GMP, or Unlicensed Medicines).
Prior experience working within a commercial affiliate of a Marketing Authorisation Holder (MAH).
Demonstrated experience in Regulatory Affairs, Pharmacovigilance, and Advertising compliance, specifically related to MAH responsibilities.
Proven track record of participation in regulatory authority inspections.
Experience serving as a Responsible Person (RP) or Deputy RP under a Wholesale Distribution Authorisation (WDA).
Strong leadership capabilities with the ability to manage and develop a small team effectively.
Excellent interpersonal and communication skills, with the ability to engage confidently across all levels of the organisation.
Highly developed organisational, analytical, problem-solving, influencing, and management skills.
Project management experience is advantageous.
Proficient in standard software applications, including word processing, spreadsheets, and data analysis tools.
Ability to thrive in a fast-paced, collaborative environment with sound decision-making and problem-solving abilities.
Strong time management and prioritisation skills, with a focus on meeting tight and overlapping deadlines.
Exceptional attention to detail, organisational skills, and accuracy in record-keeping.
Capable of working independently with minimal supervision.
Familiarity with validation methodologies.
Commercial awareness and business acumen.
A bachelor’s degree in a science or healthcare is preferred.

COMPETENCIES

Positive can-do attitude with a focus on action does not debate.
Results orientated.
Pursues a standard of excellence, relentlessly measuring and chasing to ensure targets met.
Resolves conflict constructively and works well under pressure.
Attention to detail.
Strong communication and negotiation skills.

Quality Lead RP ROI

Job Description