Quality Lead

Next Generation; Dublin; On-site; EUR 110,000 - 140,000; Full time

Job summary

Next Generation in Dublin is seeking an experienced Quality Lead to oversee pharmaceutical development activities across API/OSD, NPI, scale-up and commercialisation. You’ll lead QA oversight across analytical, manufacturing and validation, collaborating with CMC and external CMOs to maintain GMP compliance.

The role requires 10+ years in pharma QA, strong GMP manufacturing background, and hands-on experience with deviations, CAPAs, change controls and investigations, plus audits and regulatory

Qualifications

• 10+ years of experience in quality assurance within the pharmaceutical industry.
• Strong knowledge of GMP manufacturing and regulatory expectations (FDA/EU cGMP).
• Experience supporting NPI, scale-up, tech transfer or commercialisation is advantageous.

Responsibilities

• Lead Quality oversight across analytical, manufacturing and validation activities.
• Support Phase I/II manufacturing, NPI and product development activities.
• Oversee cleaning validation/verification and cross-contamination controls.
• Provide on-floor QA support and review GMP manufacturing documentation.
• Support batch disposition and preparation of documentation for QP disposition.
• Manage Quality activities including deviations, CAPAs, change controls and investigations.
• Collaborate with Manufacturing, Analytical, CMC and other technical stakeholders.
• Support audits, inspections and regulatory filings.

Skills

Quality Assurance

GMP Manufacturing

Cross-functional Collaboration

Regulatory Compliance

Analytical Testing

Job description

Quality Lead | Pharmaceutical Development

Dublin | onsite

An exciting senior Quality opportunity supporting pharmaceutical products across development, NPI, scale-up and commercialisation. You’ll work across Quality, Analytical, Manufacturing and CMC, with exposure to OSD, API, external CMOs and pharmaceutical manufacturing.

Key Responsibilities

• Lead Quality oversight across analytical, manufacturing and validation activities.
• Support Phase I/II manufacturing, NPI and product development activities.
• Oversee cleaning validation/verification and cross-contamination controls.
• Provide on-floor QA support and review GMP manufacturing documentation.
• Support batch disposition and preparation of documentation for QP disposition.
• Manage Quality activities including deviations, CAPAs, change controls and investigations.
• Collaborate with Manufacturing, Analytical, CMC and other technical stakeholders.
• Support audits, inspections and regulatory filings.

Experience Required

• 10+ years’ experience within the pharmaceutical industry.
• Strong Quality Assurance and GMP manufacturing background.
• Experience within OSD and pharmaceutical development preferred.
• Strong analytical testing and cleaning validation knowledge.
• Knowledge of FDA/EU cGMP, validation lifecycle and data integrity.
• Experience supporting NPI, scale-up, tech transfer and/or commercialisation advantageous.
• Strong communication, influencing and problem-solving skills.