Aseptic QA Team Lead — GMP Compliance & Leadership

Jobtailor; Dublin; On-site; EUR 80,000 - 110,000; Full time

Job summary

Jobtailor in Ireland seeks a QA/QA Compliance Lead to ensure aseptic manufacturing quality and cGMP adherence, guiding a team of QA professionals across environmental monitoring, deviations, CAPAs, and documentation.

You will drive training, support batch release readiness, and collaborate with manufacturing, QA, and regulatory bodies to sustain high standards and continuous improvement in a fast-paced facility.

Qualifications

• Experience in sterile GMP environments with QA function.
• Experience with QMS processes (paper and electronic).
• Experience in Grade A-D cleanrooms with RABS.
• Experience with deviations, investigations, and CAPAs.
• Strong problem-solving mindset and leadership abilities.
• Excellent verbal and written communication in English.
• Proven project management skills for multiple high-priority tasks.
• Solid understanding of EU GMP Annex 1 and ICH Q9/Q10 quality risk management.

Responsibilities

• Lead QA activities ensuring aseptic manufacture compliance.
• Oversee deviations, investigations, CAPAs, and batch records.
• Manage documentation review and approvals (MBRs, SOPs, Training).
• Mentor and coach team members; promote training and development.
• Collaborate with Manufacturing, QA, and regulatory bodies to ensure compliance.

Skills

Quality management

GMP compliance

Regulatory knowledge

Team leadership

Problem solving

English proficiency

Project management

Attention to detail

Education

Pharmaceutical degree

Bachelor's degree in Science

Tools

Veeva Vault

Trackwise

SAP

LIMS

Job description

Jobtailor in Ireland seeks a QA/QA Compliance Lead to ensure aseptic manufacturing quality and cGMP adherence, guiding a team of QA professionals across environmental monitoring, deviations, CAPAs, and documentation.

You will drive training, support batch release readiness, and collaborate with manufacturing, QA, and regulatory bodies to sustain high standards and continuous improvement in a fast-paced facility.