Director, Regulatory Compliance - EU/UK QP Lead

PCI Pharma Services; Stamullen; On-site; EUR 120,000 - 160,000; Full time

Job summary

PCI Pharma Services is seeking a senior Regulatory Compliance leader to oversee the EU/UK regulatory program, including the QP release process for Clinical and Commercial activities. You will direct the team across Ireland, the UK, and Berlin, ensuring compliance with EU GMP, HPRA requirements, and customer needs.

You will drive strategy, manage budgets, and serve as the main escalation point for regulatory issues, while maintaining oversight of product specifications and supplier lists across

Qualifications

• Bachelor’s degree in science, engineering, technology or a related discipline.
• SME in Sterile, ATMP and Annex 16 Compliance.
• Experience working within a Pharmaceutical Environment.
• Industry knowledge of EU GMP (HPRA/FDA).
• Strong organisational / time management skills.
• Effective interpersonal communications and management skills.
• Flexibility to travel between all PCI EU Pharma Sites.
• High motivation, flexibility and the ability to work on own initiative.
• At least 5-10 years’ experience in a quality management role in the Pharma industry.

Responsibilities

• Lead the implementation and execution tasks supporting right first time QP release.
• Provide QP with broad Sterile/ATMP experience.
• Maintain oversight of regulatory change and HPRA/EU requirements.
• Manage Regulatory Compliance Team across Ireland, UK, and Berlin.
• Ensure regulatory compliance activities for PCI Ireland/UK.

Skills

Sterile/ATMP

Annex 16 compliance

EU GMP knowledge

Regulatory management

Leadership

Travel flexibility

Education

Bachelor’s degree in science/engineering

Job description

PCI Pharma Services is seeking a senior Regulatory Compliance leader to oversee the EU/UK regulatory program, including the QP release process for Clinical and Commercial activities. You will direct the team across Ireland, the UK, and Berlin, ensuring compliance with EU GMP, HPRA requirements, and customer needs.

You will drive strategy, manage budgets, and serve as the main escalation point for regulatory issues, while maintaining oversight of product specifications and supplier lists across