Job Description

Role title

QHSSE Responsible Person

Business unit

DHL Global Forwarding

Location

Cedar dr, Dublin

Scope of role

Acting as a full time Responsible Person for Pharma distribution activities within the organisation and for the maintenance of the organisation’s Pharmaceutical Quality System. Ensure quality risks and issues are communicated to all relevant stakeholders and work to ensure all Quality Assurance responsibilities are met in accordance with GDP.

Reporting line

QHSSE Manager

Dotted reporting line

N/A

Direct reports

N/A

Working days and hours

9.00-17.30, Monday to Friday, or such hours deemed necessary to fulfil the requirements of the role.

Key accountabilities

Responsible Person (GDP & Regulatory Compliance)

• Act as the nominated Responsible Person on the Wholesale Distribution Authorization (WDA)
• Ensure they carry out their duties in such a way as to ensure that the wholesale distributor can demonstrate GDP compliance and that public service obligations are met
• Maintain oversight and effectiveness of the Pharmaceutical Quality Management System.
• Must fulfil their responsibilities personally and should be continuously contactable. The responsible person may delegate duties but not responsibilities.
• Ensure operations do not compromise the quality, integrity or traceability of medicinal products.
• Ensure compliance with: relevant legislation, the EU GDP Guidelines, the Medicinal Products (Control of Wholesale Distribution) Regulations 2007 (S.I. No. 538 of 2007), as amended, HPRA Guidance and Client-specific quality and regulatory requirements.
• Oversee supplier and customer qualification and approval processes.
• Approval of GDP quality and technical agreements.
• Ensure subcontracted activities comply with GDP requirements.
• Coordinate and manage product recalls, quality incidents, deviations and escalations.
• Make disposition decisions for returned products where DHL retains RP accountability.
• Act on client RP instructions regarding rejected, recalled or falsified products.
• Host and coordinate HPRA inspections and client quality audits.
• Ensure Licence holder is kept fully updated.
• Provide data and updates to support with management reviews .
• Communicate emerging quality risks and regulatory issues to relevant stakeholders.

Training & Competency Management

• Develop, implement and maintain GDP and quality training programmes.
• Ensure all mandatory and supplementary training requirements are delivered in accordance with:
• Company policies.
• Industry regulations.
• Customer requirements.
• Maintain oversight of training records and competency assessments.
• Ensure the Training Database remains accurate, validated and up to date.
• Monitor training completion against agreed targets and KPIs.
• Produce regular compliance and training reports for management review.
• Identify competency gaps and implement corrective training plans.
• Support induction and ongoing development programmes across operations.
• Ensure training effectiveness is periodically reviewed and demonstrated.

Quality Systems & Documentation

• Approval of all GDP Standard Operating Procedures (SOPs), Work Instructions and controlled documents
• Coordinate document review cycles and document control activities.
• Ensure all quality records are complete, accurate and retained in accordance with GDP requirements.
• Manage change control activities impacting GDP processes.
• Support CAPA investigations and effectiveness reviews.
• Ensure self-inspections are conducted according to schedule and corrective actions implemented.
• Monitor quality metrics and compliance trends.
• Support continuous improvement projects to enhance quality performance and operational compliance.

Customer, Supplier & Stakeholder Management

• Meet regularly with customers to review service performance and compliance requirements.
• Support customer implementations, audits and project activities.
• Investigate and communicate quality-related regulatory updates and customer requirements.
• Collaborate with Operations, Commercial, Quality and Customer Service teams.
• Build strong working relationships with regulatory authorities, customers and external partners.
• Support business growth opportunities through provision of quality and compliance expertise.

Management & Reporting

• Prepare quality, compliance and training reports to management.
• Support management review meetings and provide expert GDP guidance.
• Analyse quality and training performance metrics.
• Escalate significant risks, compliance concerns and emerging trends.
• Support strategic quality initiatives and business compliance objectives.
• Deputise for other nominated Responsible Persons where appropriately authorised
• Ensure operational compliance to all revenue and international trade legislative requirements, and all requirements under Data Protection Legislation in addition to all DHL Global Forwarding Ireland policies and procedures (H&S, Quality, Environmental, HR, etc), and work in a manner that supports the Company environment programme.
• Participate in the implementation of operational processes and perform work to the standards of Good Distribution practice (GDP) for Life Science business, as required.

Competencies

Relationships with others

Communicates openly and honestly, treats others with respect, values diversity, builds trust, maintains effective relationships, stays calm with difficult individuals, and listens well.

Teamwork

Committed to fulfilling their role, supports team members, shares knowledge freely, contributes to team spirit, collaborates to achieve objectives, maintains quality and quantity of work, and motivates colleagues.

Customer orientation

Bases decisions on customer impact, builds and maintains effective relationships, focuses on customer needs, solves problems quickly, and strives to exceed customer expectations.

Problem solving

Identifies issues and opportunities, uses formal techniques to find root causes, evaluates risks, analyses causes and effects, solves problems quickly, establishes effective processes, and communicates solutions.

Commitment to excel

Achieves targets, takes on additional roles, reviews processes, seeks feedback, adheres to DHL's values, embraces change, is flexible, seeks opportunities, provides advice, and keeps skills updated.

Procedural skills

Organises workload, selects and follows appropriate procedures, meets deadlines, improves existing procedures, and creates new procedures.

Attention to detail

Works accurately with large amounts of data, applies high attention to detail in written documents, and ensures procedural completion.

Experience and qualifications

Expected experience

• Background in transportation, logistics
• Previous RP experience
• GDP experience
• Lead auditor for ISO 9001

Expected qualifications

• Pharmacy or life sciences degree preferred

The above statements are intended to describe the general nature and level of work performed by people assigned to this role. They are not intended to be construed as an exhaustive list of all job duties performed. The Company reserves the right to revise or amend duties at any time.

We are committed to equal opportunity and reject any forms of discrimination. The basis for employee selection at DHL Group is qualifications, performance, skills and experience.