Quality Lead RP ROI

Overview

Company Background
Uniphar Group PLC is one of two full line pharmaceutical wholesalers operating in the Irish market. The company has a turnover expected to be in excess of €1.2billion for 2015 and operates from its headquarters in Citywest, Dublin. The group serves as the middle man between manufacturers and pharmacies, handling bulk purchases and distributing medicines in units across a wide product range. It maintains wholesale depots in Dublin, Cork, Limerick and Sligo, and runs the Citywest Distribution Centre (CDC), a €65M warehousing and distribution facility. Uniphar engages across the pharmaceutical/health supply chain and has grown through acquisitions and IT investments. The group employs approximately 550 people and has expanded its services through platforms such as Star Medical and Point of Care Point.

People & Culture: Uniphar emphasizes hiring high-potential individuals and developing long-term careers, with an emphasis on cultural fit, adaptability, and results orientation.

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 and results.
• Results-oriented; pursues a standard of excellence and measures progress toward targets.
• Resolves conflict constructively and works well under pressure.
• Attention to detail; strong communication and negotiation skills.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Quality Assurance

Industries

• Pharmaceutical Manufacturing

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