In-House QP & QA Manager – Pharma (Hybrid, Ireland)

Morgan McKinley; Dublin; Hybrid; EUR 90,000 - 120,000; Full time

Job summary

Morgan McKinley is partnering with a dynamic Irish pharmaceutical company to hire a Qualified Person (QP) & Quality Assurance Manager. This hybrid, full-time role oversees HPRA liaison, PQS governance, and batch certification.

You will lead supplier audits, CAPA, change control, deviation management, and QRM, while ensuring HPRA inspections readiness and centralizing QA from external consultants. Strong Irish MIA QP status is essential.

Qualifications

• Must be named or previously named as QP on an Irish MIA for human medicinal products.
• Minimum 2 years' post-approval batch certification experience.
• Strong knowledge of EU GMP, Annex 16 and supplier management.
• Independent, pragmatic, lean-team fit for a fast-paced environment.
• Full authorization to work in Ireland with on-site Dublin 2 presence.

Responsibilities

• HPRA & MIA oversight with direct regulatory communications.
• Review and certify commercial batches per EU GMP, Annex 16 and MAU/SOPs.
• Lead PQS, CAPA, change control, deviations and QRM programs.
• Qualify/audit CMOs, labs, packaging sites, and 3PLs; maintain quality agreements.
• Ensure inspection readiness and transition from external QA consultants.
• Collaborate with Regulatory Affairs and Supply Chain on transfers and launches.
• Conduct domestic and international audits of suppliers as needed.

Skills

QP experience

Regulatory liaison

QA leadership

Audit readiness

Cross-functional

Education

QP status (Irish MIA)

Job description

Morgan McKinley is partnering with a dynamic Irish pharmaceutical company to hire a Qualified Person (QP) & Quality Assurance Manager. This hybrid, full-time role oversees HPRA liaison, PQS governance, and batch certification.

You will lead supplier audits, CAPA, change control, deviation management, and QRM, while ensuring HPRA inspections readiness and centralizing QA from external consultants. Strong Irish MIA QP status is essential.