Job Description

Qualified Person (QP) — Sterile Biologics Manufacturing

Location: Midlands, Ireland | Type: Permanent | Salary: Competitive, DOE

The Business

Our client is a sterile biologics manufacturing site in the Midlands, producing injectable biologic products for regulated markets. The site operates to EU GMP and is scaling up production, which has created a permanent QP requirement to strengthen batch certification capability and support ongoing regulatory readiness.

The Role

As Qualified Person, you'll take personal accountability for certifying batches of sterile biologic product for release, in line with Annex 16 and the site's Marketing Authorisations. You'll work closely with Quality, Manufacturing and Regulatory Affairs to make sure every batch released meets the required standard — and you'll have the authority to hold a batch back when it doesn't.

This is a site where QP judgement carries real weight. You'll be expected to understand the manufacturing process well enough to make an informed release decision, not just review paperwork.

Key Responsibilities

• Certify batches of sterile biologic drug product for release, taking full personal and legal responsibility under Annex 16
• Review batch records, deviations, change controls and investigations before certification, and make an independent judgement on product quality
• Act as a named QP on the site's Manufacturer's/Importer's Authorisation (MIA) and support any related regulatory submissions or variations
• Work with Manufacturing and Quality teams to resolve issues that affect batch disposition, including deviations and OOS results
• Support internal and external audits, and represent the QP function during regulatory inspections
• Contribute to the site's quality systems, including change control, CAPA and continuous improvement of release processes
• Keep up to date with evolving GMP, Annex 16 and biologics-specific regulatory requirements, and flag where the site needs to adapt

What You'll Need

• Qualifications and experience that meet the requirements to act as a Qualified Person under EU GMP (Annex 16, Directive 2001/83/EC or equivalent)
• Current or previous experience as a named QP, ideally within sterile/aseptic manufacturing
• Strong working knowledge of biologics manufacturing — upstream/downstream processing, aseptic fill-finish, or related sterile production
• Confidence to make an independent, defensible release decision, including when that means challenging the site
• Experience supporting regulatory inspections (HPRA, FDA, or equivalent) is a strong advantage
• Clear communicator who can work across Quality, Manufacturing and Regulatory functions

What's On Offer

• Permanent, site-based role in the Midlands with a growing sterile biologics operation
• Competitive salary, doe, reflecting the seniority and personal accountability of the role
• The chance to shape release and quality processes on a site that's scaling up, rather than maintain an already-fixed system

Next Step

If this sounds like the right fit — or you know someone it would suit — get in touch for a confidential conversation about the site, the team and the detail of the role.