About the job
Ready to make an impact in a dynamic, fast-paced biopharma environment?
We're looking for an experienced Qualified Person (QP) to join a high-performing quality team based in Cork. This hybrid contract role (12 months) offers the opportunity to contribute to the safe and compliant release of both commercial and clinical drug products-with a focus on sterile manufacturing and biologics.
Key Responsibilities
- Take full responsibility as QP for batch certification in line with EU Directives (2001/83/EC, 2001/20/EC) and Annex 16/13 as applicable.
- Ensure product release meets GMP requirements and complies with Marketing Authorisation (MA) or Clinical Trial Authorisation (CTA) standards.
- Provide technical QA leadership, ensuring robust compliance across manufacturing and supply processes.
- Support internal audits and regulatory inspections (HPRA, FDA, etc.), and represent Quality in cross-functional teams.
- Participate in management reviews, continuous improvement initiatives, and oversee Product Quality Reviews (PQRs).
- Monitor and promote adherence to site licenses and GxP regulations.
Qualifications & Experience
- QP status with a minimum of 3–5 years experience acting as a named QP under an MIA/IMP MIA.
- 5+ years in Quality Assurance within an EU-licensed pharma/biopharma facility.
- Hands-on experience in aseptic/sterile manufacturing, biologics, or clinical trial materials is highly desirable.
- Proven track record in regulatory inspection readiness, technical writing, and quality system oversight.
- Strong knowledge of EU/FDA GMP regulations and global quality standards.
- Effective communication, mentoring, and decision-making skills.
- Ability to analyze risk and drive effective, compliant solutions.
Why Join?
- Be part of a company that’s passionate about advancing healthcare through innovation.
- Gain experience across clinical and commercial operations in a supportive, collaborative setting.
- Work in a hybrid capacity, balancing on-site influence with flexibility.
