Quality Compliance Manager

Hollybank Trustees Ltd; Leinster; On-site; EUR 95,000 - 120,000; Full time

Job summary

PHX Ireland seeks an experienced quality leadership professional to oversee GDP compliance and HPRA-aligned GMP processes within the Quality Management System. The role supports Responsible Persons, maintains inspection readiness, and drives CAPA, change control and supplier qualification across PHX Ireland sites.

Five years in a pharma-quality leadership role is required, with strong HPRA GDP knowledge and GMP understanding.

Qualifications

• Minimum of five years’ experience in a team leader or management role in pharmaceutical quality, wholesale distribution, manufacturing, logistics or regulated healthcare.

Responsibilities

• Provide quality compliance leadership for GDP and applicable GMP system processes within the Quality Management System.
• Support Responsible Person and Deputy Responsible Persons to maintain compliance with HPRA GDP expectations.
• Oversee Wholesale Distribution Authorisation requirements and site operations to HPRA GDP expectations and licencing scope.
• Maintain inspection readiness with up-to-date records, procedures and training for regulatory inspection.
• Manage deviation, investigation and CAPA processes with root cause analysis and effective corrective actions.
• Oversee change control activities including regulatory/GDP impact assessment and closure.
• Maintain and improve document control ensuring procedures and records are controlled and aligned with regulatory needs.
• Lead or support internal audits and self-inspection across sites and quality systems.
• Manage supplier/customer qualification processes including bona fides checks and vendor approvals.
• Ensure quality oversight of storage, temperature control, cold chain, transport, returns and destruction processes.
• Support qualification and monitoring of storage/transport conditions to protect product quality.
• Maintain training management for GDP and GMP activities including training effectiveness.

Skills

Team leadership

HPRA GDP knowledge

EU GDP guidelines

Quality Management System

GMP principles

Regulatory compliance

Job description

Our people make the difference. Here at PHX Ireland, we strive to be a place for everyone - where each and every one of us can be our true, authentic selves, every single day.

For us, individuality sparks new ideas, shapes new approaches and brings us powerful new perspectives. It’s the heartbeat of our innovation, creativity, and success. Which is why, at PHX Ireland, we don’t just embrace our differences – we celebrate them.

Across United Drug, McCabes Pharmacy, and TCP Homecare, in every location and every role, the way we work makes us who we are – and that’s something we are really proud of. Which is why we’ve summed up our ethos in our six PHX Ireland values; Customer focused, Quality driven, collaborative, ambitious, innovative, and inclusive.

Keeping our workspaces working keeps medicines on the move.

Why You’ll Love Working With Us:

• Family comes first: Life Stage Policies including maternity and paternity pay
• Perks you’ll actually use: Generous in store discounts
• We’ve got your back: employee assistance programme and wellbeing initiatives
• Belonging at Work: Inclusive, welcoming team culture where you’re valued for you.

What You’ll Be Doing:

• Provide quality compliance leadership for GDP and applicable GMP system processes within the Quality Management System.
• Support the Responsible Person and Deputy Responsible Persons in maintaining ongoing compliance with Wholesale Distribution Authorisation requirements and HPRA GDP expectations.
• Support oversight of Wholesale Distribution Authorisation requirements, ensuring that authorised activities, site operations, procedures and records remain aligned with HPRA GDP expectations and approved licence scope.
• Maintain inspection readiness by ensuring quality processes, records, procedures, training and evidence are complete, current, accurate and readily available for regulatory inspection.
• Manage and improve the deviation, investigation and CAPA processes, ensuring timely root cause analysis, effective corrective and preventive actions, appropriate risk assessment and documented effectiveness checks.
• Oversee change control activities, including quality impact assessment, regulatory/GDP impact assessment, action tracking and completion verification.
• Maintain and improve the document control system, ensuring procedures, forms, records and quality agreements are controlled, approved, reviewed and aligned with current regulatory and business requirements.
• Lead or support the internal audit and self-inspection programme across relevant sites, functions and quality systems, ensuring findings are documented, risk assessed and closed effectively.
• Manage supplier, customer and service provider qualification processes, including bona fides checks, vendor approval, outsourced activity oversight and periodic review.
• Ensure appropriate quality oversight of storage, temperature control, cold chain, transport, returns, quarantine, rejected goods and destruction processes.
• Support qualification, mapping, monitoring and periodic review of storage and transportation conditions to ensure medicinal product quality is maintained throughout the supply chain.
• Maintain effective training management processes for GDP and applicable GMP activities, including role-based training, training effectiveness and compliance monitoring.
• Support quality risk management activities and ensure risks to product quality, patient safety, data integrity and regulatory compliance are appropriately identified, assessed, controlled and reviewed.
• Prepare, review and report relevant quality metrics, trends and management review inputs, including deviations, CAPA, complaints, change controls, audits, training, recalls and supplier performance.
• Promote a strong quality culture through coaching, clear communication, cross-functional collaboration and proactive resolution of quality issues.

What You’ll Need to Succeed:

• Minimum of five years’ experience in a team leader or management role within a pharmaceutical quality, wholesale distribution, manufacturing, logistics or regulated healthcare environment.
• Previous experience acting as a Responsible Person, Deputy Responsible Person or in a role with delegated RP responsibilities within a wholesale distribution or medicinal product supply chain environment.
• Strong working knowledge of HPRA GDP expectations, EU GDP Guidelines, medicinal product wholesale distribution requirements and Quality Management System principles.
• Working knowledge of GMP principles relevant to outsourced activities, supplier oversight, product quality defects, secondary packaging interfaces or other applicable regulated activities.

About United Drug

United Drug is Ireland’s largest pharmaceutical distribution company and was originally founded by a group of pharmacists in Ballina, Mayo in 1948. In 2022 United Drug became part of the PHOENIX group and is now part of Europe’s leading healthcare provider in the sector. Employing more than 650 staff across operations in Dublin, Limerick and Mayo, we partner with more than 1,900 pharmacies, hospitals, clinics and primary care centres across Ireland. Our business spans across three business units; United Drug Wholesale, United Drug Distribution and United Drug Consumer – all leaders in their respective categories.

About PHX Ireland & PHOENIX Group

We are comprised of United Drug, Ireland’s leading pharmaceutical wholesaler and distributor; McCabes Pharmacy, Ireland’s leading community pharmacy chain; and TCP Homecare, innovators in clinical home nursing services and direct to patient delivery solutions.

PHX Ireland Group employs over 1,800 people, operates 5 distribution centres and pharmacies nationwide, delivering over 85 million packs to Irish pharmacies and hospitals and serving 500,000 patients each year.

PHX Ireland is part of the PHOENIX group, Europe’s leading healthcare provider. Headquartered in Mannheim, Germany, the PHOENIX group brings together more than 48,000 employees from 29 countries, includes 223 pharmaceutical distribution sites, and more than 3200 owned pharmacies and 17000 partner pharmacies.

We strive to foster an open and inclusive environment, embracing applications from individuals of all backgrounds. Our commitment lies in ensuring an accessible interview process for all candidates. If you require additional support or accommodations to attend an interview, we kindly encourage you to reach out to [e-mail]