Qualified Person

Morgan McKinley; Dublin; On-site; 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

Role: Qualified Person (QP) & Quality Assurance Manager

Working Arrangement: Full-time, Permanent (Hybrid: Minimum 3 days/week on-site)

About My Client

My client is a dynamic, rapidly growing Irish pharmaceutical company specializing in complex generics and biosimilars. To support their expanding pipeline and strengthen operational independence, they are bringing their core QP and QA capabilities in-house. They are seeking a proactive, hands-on Qualified Person & QA Manager to drive regulatory engagement, oversee the Pharmaceutical Quality System (PQS), and lead batch certification activities.

Position Summary

This is a high-impact, dual-function leadership role ideal for an experienced QP who thrives in a lean, fast-paced environment. You will serve as the primary quality figurehead-managing direct HPRA interactions, leading the transition of QA/QP responsibilities from external consultancies, and certifying commercial batches once registered on the company's Manufacturer's/Importer's Authorisation (MIA).

Key Responsibilities

• HPRA & MIA Oversight: Act as the named in-house QP on the company's MIA, managing direct HPRA communications, variations, inspections, and regulatory queries.




• Batch Release & Certification: Review and certify commercial finished product batches in accordance with EU GMP, Annex 16, marketing authorisations, and internal SOPs.




• PQS Leadership: Own and continuously improve the Pharmaceutical Quality System, including CAPA, change control, deviation management, Quality Risk Management (QRM), and self-inspection programs.




• Vendor & Supply Chain Management: Qualify and audit external contract manufacturing organizations (CMOs), testing laboratories, packaging sites, and 3PL providers. Draft and maintain Quality Agreements and oversee supplier performance.




• Inspection Readiness: Maintain ongoing audit readiness for HPRA/regulatory inspections and lead the internal transition from outsourced QA consultants to an in-house structure.




• Cross-Functional Support: Partner closely with Regulatory Affairs and Supply Chain on technical transfers, product launches, stability studies, and outsourced Pharmacovigilance (GVP) vendor monitoring.




• Auditing & Travel: Conduct domestic and international audits of CMOs, material suppliers, and service providers as required.

Essential Candidate Profile

• HPRA QP Status: Must be currently or previously named as a Qualified Person (QP) on an Irish MIA for human medicinal products, with direct HPRA engagement history.




• Proven QP Experience: Minimum of 2 years' active, post-approval operational experience performing batch certification (QP course completion/eligibility alone is insufficient).




• Technical QA Expertise: Strong working knowledge of EU GMP, Annex 16, quality systems, supplier management, and root-cause investigations within outsourced manufacturing models.




• Practical & Independent: High degree of self-reliance, with a pragmatic, "roll-up-your-sleeves" attitude suited to a lean corporate team structure.




• Location & Eligibility: Full authorization to work in Ireland, ability to work on-site in Dublin 2 at least 3 days per week, and flexibility for occasional international audit travel.

Desirable Criteria

• Hands-on experience with sterile products, injectables, complex generics, or biosimilars.


• Familiarity with third-country imports and EU GMP Annex 21.


• Good Distribution Practice (GDP) exposure or Responsible Person (RP) experience.


• General oversight experience of outsourced Pharmacovigilance (PV) operations.