Qualified Person / Responsible Person – Biopharmaceutical Industry
Location: Dublin
Sector: Pharmaceutical / Clinical Supply Chain
Type: Full-Time | Contract

We are recruiting on behalf of a leading biopharmaceutical company for a Qualified Person (QP) / Responsible Person (RP) to play a pivotal role in ensuring the quality, compliance, and regulatory readiness of clinical supply chain operations.

Key Responsibilities:

• QP certification and batch release of clinical supplies

• Serve as RP under a Wholesale Distribution Authorisation (WDA) for Pre-Approval Access

• Lead and support GMP/GDP inspections and audits

• Advise stakeholders on quality improvements, compliance, and risk mitigation

• Maintain and update the Site Master File and Manufacturer’s Authorisation

• Ensure timely communication of quality issues to partners and leadership

• Review and approve SOPs and procedural documents

• Contribute to global audit planning and continuous improvement programs

• Stay ahead of global regulatory changes and integrate them into quality systems

• Influence external quality standards through engagement with regulators and industry bodies

Candidate Profile:

• Degree in science, engineering, or related discipline

• Eligible to act as a Qualified Person (QP) under EU regulations

• Experience as a Responsible Person (RP) under a WDA is preferred

• Minimum 10 years in the pharmaceutical/biopharma industry