Qualified Person

Qualified Person

Key Responsibilities:

• Serve as Qualified Person (QP) for the certification and batch release of clinical trial supplies in compliance with EU regulations.
• Act as Responsible Person (RP) on the Wholesale Distribution Authorisation (WDA) for Pre-Approval Access activities.
• Support regulatory authority inspections and audits (GMP/GDP) across the global clinical and commercial supply chain.
• Advise cross-functional teams on quality issue management, regulatory compliance, and continuous process improvement.
• Monitor and integrate global regulatory trends, ensuring quality systems and operations remain compliant and efficient.
• Maintain and update Site Master Files and Manufacturing Authorisations.
• Escalate and communicate significant quality issues or deviations promptly to stakeholders and senior management.
• Review, approve, and manage procedural and quality documentation.
• Actively contribute to cross-functional project teams and strategic working groups within Quality and Supply Chain functions.
• Provide expert guidance to ensure alignment with external regulations and internal policies at global and cross-functional levels.
• Represent the organization in interactions with regulators, trade bodies, and professional associations to influence industry practices and policies.
• Identify quality and compliance risks and contribute to mitigation planning.
• Offer input into the development of global audit programs, informed by trends, risk signals, and compliance gaps.
• Pursue continuous professional development, including site visits, training, and audit participation.
• Support Operational Excellence (OPEX) initiatives and champion continuous improvement in quality systems and culture.

Required Qualifications & Experience:

• Bachelor's degree (or higher) in a scientific, engineering, or related discipline.
• Minimum of 10 years' experience in the pharmaceutical or biopharmaceutical industry.
• Eligible to act as a Qualified Person (QP) under EU directives on the Manufacturing/Importation Authorisation.
• Previous experience as a Responsible Person (RP) under a WDA is strongly preferred.
• In-depth knowledge of ICH guidelines, GMP/GDP standards, data integrity principles, and clinical supply chain operations.
• Demonstrated success in building and leading high-performing quality teams and working effectively across global, cross-functional environments.
• Excellent communication skills with a proven ability to influence, engage, and drive results across matrixed and international teams.
• Strong leadership qualities and commitment to fostering a culture of quality and continuous improvement.

The Next Step for you:

• Should this position be of interest to you please submit your CV to Barry O'Mahony from Next Generation Recruitment using the apply button.
• Next Generation are specialists in Supply Chain, Procurement, Engineering, Quality, Technical and Operation (permanent, contract and temporary) positions.
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