Quality Lead

Next Generation Recruitment; Dublin; On-site; EUR 110,000 - 150,000; Full time

Job summary

Next Generation Recruitment is seeking a Senior Quality Lead for Pharmaceutical Development in Dublin, onsite. You will oversee QA across analytical qualification, method validation, stability, and data integrity, and own the cleaning validation program while collaborating across CMC, analytical development, and manufacturing.

The role requires 10+ years in pharma, strong QA and regulatory knowledge, and experience with documentation systems like Veeva, TrackWise, ValGenesis, and SAP is a plus.

Qualifications

• Bachelor's degree in a scientific discipline or equivalent required.
• 10+ years of pharmaceutical industry experience.
• Strong QA, analytical, manufacturing and cleaning validation experience.
• Experience with FDA/EU cGMP, data integrity and validation lifecycle principles.
• Experience with Veeva, TrackWise Digital, ValGenesis and/or SAP advantageous.

Responsibilities

• Provide QA oversight of analytical qualification, method validation, stability and data integrity.
• Own the Cleaning Validation and Cleaning Verification programme.
• Provide hands-on QA support for GMP manufacturing and on-floor activities across product development and manufacturing programmes.
• Support batch disposition, batch record review and QP disposition.
• Review deviations, CAPAs, change controls, SOPs and risk assessments.
• Partner with Analytical Development, Manufacturing and Regulatory/CMC teams.
• Support GMP audits, inspections and regulatory activities.

Skills

QA experience

Analytical development

Manufacturing

Cleaning validation

Data integrity

Regulatory knowledge

Stakeholder management

Problem-solving

Education

BSc in science

Tools

Veeva

TrackWise Digital

ValGenesis

SAP

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

• Provide QA oversight of analytical qualification, method validation, stability and data integrity.
• Own the Cleaning Validation and Cleaning Verification programme.
• Provide hands-on QA support for GMP manufacturing and on-floor activities across product development and manufacturing programmes.
• Support batch disposition, batch record review and QP disposition.
• Review deviations, CAPAs, change controls, SOPs and risk assessments.
• Partner with Analytical Development, Manufacturing and Regulatory/CMC teams.
• Support GMP audits, inspections and regulatory activities.

Experience Required

• BSc in a scientific discipline or equivalent.
• 10+ years' pharmaceutical industry experience.
• Strong QA, analytical, manufacturing and cleaning validation experience.
• OSD experience highly desirable.
• Strong knowledge of FDA/EU cGMP, data integrity and validation lifecycle principles.
• Experience with Veeva, TrackWise Digital, ValGenesis and/or SAP advantageous.
• Strong stakeholder management and problem-solving skills.