Biopharma External QA Lead – Quality Systems & AI

LSC, Life Science Consultants; Cork; On-site; EUR 47,000 - 71,000; Full time

Job summary

LSC invites applications for an External QA Quality Associate to join a Cork-based biopharmaceutical company manufacturing low-volume bulk API for Phase III trials and long-term market support. The role requires at least 2 years of biopharma QA/Regulatory experience and involves leading QA metrics and digital initiatives.

Key responsibilities include governance of Deviations, CAPAs, Change Controls and cross-functional meetings to ensure timely closure, as well as development of QA metrics and

Qualifications

• Bachelor's Degree in science or engineering.
• Minimum 2+ years of biopharmaceutical QA/Regulatory experience.
• Strong data analysis skills; proficient in Excel; Power BI and AI tools desirable.

Responsibilities

• Perform Quality Systems Metric Review for GEO and oversee metrics and trending to drive on-time closure of Quality records.
• Lead and support development and implementation of digital, AI-enabled and automation initiatives for External Quality.
• Manage routine cross-functional meetings to ensure timely closure of Deviations, CAPAs and Change Control with leadership endorsement.
• Develop and report metrics and standardize these across the Organization.
• Coordinate monthly governance site quality review team (SQRT) meeting for GEO.
• Partner with Global Quality Systems Management Team and cross-functional groups to ensure proper application of the QMS.

Skills

Quality systems

Data analysis

Excel

Power BI

AI tools

Education

Bachelor's Degree in science or engineering

Tools

Power BI

AI tools

Job description

LSC invites applications for an External QA Quality Associate to join a Cork-based biopharmaceutical company manufacturing low-volume bulk API for Phase III trials and long-term market support. The role requires at least 2 years of biopharma QA/Regulatory experience and involves leading QA metrics and digital initiatives.

Key responsibilities include governance of Deviations, CAPAs, Change Controls and cross-functional meetings to ensure timely closure, as well as development of QA metrics and