QA Lead: Regulatory Compliance & QMS Champion

Curium Pharma; Blackrock; On-site; EUR 90,000 - 120,000; Full time

Job summary

Curium Pharma in Ireland seeks a Lead, Site Quality to ensure HPRA/GMP compliance and to lead the QA/QC teams. You will act as Qualified Person on the site licence, manage regulatory inspections and maintain the Validation Master Plan, ensuring the site remains in a validated state.

You will drive a culture of excellence, oversee product release, CAPAs, deviations and changes, and provide QA support for PET product development, while keeping training and documentation current.

Qualifications

• Degree level in Pharmacy, Chemistry, Pharmaceutical Chemistry or Biology
• Qualified Person
• 5 years on an HPRA license
• 5-10 years' experience in QMS
• Extensive experience in staff management
• Strong leadership and regulatory knowledge

Responsibilities

• Act as Qualified Person (QP) and named Quality Controller on the company licence.
• Ensure GMP, HPRA, EP and SmPC requirements.
• Lead regulatory inspections, responses, internal self-inspections and supplier audits.
• Approve batch documentation, QC results, master templates and product release.
• Review deviations, OOS investigations, CAPAs and changes.
• Own and improve the site QMS; manage deviations, investigations, CAPA and change control.

Skills

Radiation knowledge

Radiopharmaceutical market knowledge

Strategic thinking

Business development

Leadership

Communication skills

Education

Degree in Pharmacy or related

Qualified Person

HPRA license

QMS experience 5-10 years

Job description

Curium Pharma in Ireland seeks a Lead, Site Quality to ensure HPRA/GMP compliance and to lead the QA/QC teams. You will act as Qualified Person on the site licence, manage regulatory inspections and maintain the Validation Master Plan, ensuring the site remains in a validated state.

You will drive a culture of excellence, oversee product release, CAPAs, deviations and changes, and provide QA support for PET product development, while keeping training and documentation current.