Remote External QA Manager – CMO Quality & Compliance

Team Horizon; Dublin; Remote; EUR 80,000 - 100,000; Full time

Job summary

A leading biotech company is seeking an External QA Manager to provide quality and compliance oversight, primarily on a remote basis. The ideal candidate will have over 10 years of experience in the biotech or pharmaceutical industry, particularly in Aseptic Manufacturing, and possess strong project management and analytical skills. This role offers flexibility and the chance to impact quality standards at contract labs and CMOs.

Qualifications

• 10+ years of experience in the biotech or pharmaceutical industry.
• Ability to negotiate and influence senior stakeholders.
• Demonstrated ability to lead cross-functional teams.

Responsibilities

• Ensure Quality and Compliance Oversight of CMOs.
• Lead preparation for Regulatory Inspections.
• Review and approve Master Batch Records.

Skills

Quality experience at Aseptic Manufacturing facilities

Strong project management skills

Analytical skills

Problem-solving skills

Job description

A leading biotech company is seeking an External QA Manager to provide quality and compliance oversight, primarily on a remote basis. The ideal candidate will have over 10 years of experience in the biotech or pharmaceutical industry, particularly in Aseptic Manufacturing, and possess strong project management and analytical skills. This role offers flexibility and the chance to impact quality standards at contract labs and CMOs.