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
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HPRA & MIA Oversight: Act as the named in-house QP on the company's MIA, managing direct HPRA communications, variations, inspections, and regulatory queries.
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Batch Release & Certification: Review and certify commercial finished product batches in accordance with EU GMP, Annex 16, marketing authorisations, and internal SOPs.
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PQS Leadership: Own and continuously improve the Pharmaceutical Quality System, including CAPA, change control, deviation management, Quality Risk Management (QRM), and self-inspection programs.
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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.
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Inspection Readiness: Maintain ongoing audit readiness for HPRA/regulatory inspections and lead the internal transition from outsourced QA consultants to an in-house structure.
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Cross-Functional Support: Partner closely with Regulatory Affairs and Supply Chain on technical transfers, product launches, stability studies, and outsourced Pharmacovigilance (GVP) vendor monitoring.
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Auditing & Travel: Conduct domestic and international audits of CMOs, material suppliers, and service providers as required.
Essential Candidate Profile
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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.
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Proven QP Experience: Minimum of 2 years' active, post-approval operational experience performing batch certification (QP course completion/eligibility alone is insufficient).
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Technical QA Expertise: Strong working knowledge of EU GMP, Annex 16, quality systems, supplier management, and root-cause investigations within outsourced manufacturing models.
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Practical & Independent: High degree of self-reliance, with a pragmatic, "roll-up-your-sleeves" attitude suited to a lean corporate team structure.
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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
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Hands-on experience with sterile products, injectables, complex generics, or biosimilars.
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Familiarity with third-country imports and EU GMP Annex 21.
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Good Distribution Practice (GDP) exposure or Responsible Person (RP) experience.
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General oversight experience of outsourced Pharmacovigilance (PV) operations.
