Quality Specialist

About the role

We are seeking a Quality Specialist to provide quality oversight of outsourced drug substance manufacturing activities in the Sligo region. Reporting to the VP of Quality, you will act as the sponsor’s Person in Plant and ensure compliance with regulatory and product requirements.

Key responsibilities

• Act as the sponsor’s Person in Plant (PiP) at designated drug substance manufacturing sites.
• Review manufacturing batch documentation for compliance with approved product dossiers and regulatory standards.
• Provide quality oversight of third‑party manufacturing partners through routine engagement, performance monitoring and quality metrics.
• Participate in quality risk assessments supporting product changes, deviations and quality events.
• Assist in the development, review and maintenance of Standard Operating Procedures (SOPs).
• Support investigations related to temperature excursions and contribute to shipping lane risk assessments and validation activities.
• Provide general quality and compliance support as directed by the Vice President of Quality.
• Foster strong relationships with internal stakeholders and external manufacturing partners to ensure high product quality and compliance.

Required profile

• Bachelor’s degree in Chemistry (preferred) or another relevant scientific discipline.
• Minimum 3 years of experience in the pharmaceutical industry.
• Experience supporting small‑molecule pharmaceutical products preferred.
• Experience working with contract manufacturing organisations (CMOs) advantageous.
• Strong understanding of EU GMP regulations and pharmaceutical quality requirements.
• Ability to interpret regulatory expectations and implement sustainable quality practices.
• Understanding of pharmaceutical batch documentation review.
• Experience with small‑molecule synthetic manufacturing processes desirable.
• Familiarity with quality risk management principles and pharmaceutical investigations is an advantage.
• Excellent written and verbal communication skills.
• Strong organisational skills with the ability to manage multiple priorities.

Required skills

• EU GMP regulations
• Pharmaceutical batch documentation review
• Quality risk management
• SOP development and maintenance
• Small‑molecule synthetic manufacturing processes
• Contract manufacturing oversight

What we offer

• Competitive salary €45,000–€55,000 per year, depending on experience.
• Remote working within the Sligo region with weekly visits to the manufacturing facility (hybrid model).
• Opportunity to work in an innovative clinical‑stage pharmaceutical company developing therapies for rare diseases.
• Exposure to global contract manufacturing operations and cross‑functional collaboration.
• Supportive, collaborative environment with professional development opportunities.