Hybrid QA Lead - Batch Release for Sterile Products

Sanofi Group; Waterford; Hybrid; EUR 73,000 - 98,000; Full time

Job summary

Sanofi Waterford seeks a Batch Release Lead Qualified Person to oversee steri le product release and ensure cGMP compliance. The role reports to the Head of Quality Lyo APU and requires hands-on batch certification, quality document review, and cross-team collaboration.

The candidate will mentor QA specialists, lead quality-improvement projects, and ensure timely releases while maintaining high safety standards in a 3 days onsite, 2 days remote per week pattern.

Qualifications

• You've worked as a Qualified Person certifying and releasing batches on a manufacturing license
• Familiar with regulatory requirements for sterile manufacturing including Annex 1
• Strong communicator who can influence across teams and deliver quality outcomes
• Fluent English and Ireland-based qualification meeting eligibility for Qualified Person status

Responsibilities

• Make sure all products released from the site meet quality and safety standards
• Review and sign off on quality documents to confirm standards
• Collaborate with other teams to resolve quality issues and close actions
• Investigate product issues thoroughly and ensure full resolution before release
• Follow safety procedures and raise safety concerns when needed
• Lead projects to improve quality processes across the site
• Mentor and support quality team members to grow their skills

Skills

Qualified Person

Regulatory knowledge

Communication skills

Sterile manufacturing

English fluency

Education

Master's degree or Pharmacy qualification

Job description

Sanofi Waterford seeks a Batch Release Lead Qualified Person to oversee steri le product release and ensure cGMP compliance. The role reports to the Head of Quality Lyo APU and requires hands-on batch certification, quality document review, and cross-team collaboration.

The candidate will mentor QA specialists, lead quality-improvement projects, and ensure timely releases while maintaining high safety standards in a 3 days onsite, 2 days remote per week pattern.