Batch Release Lead, Qualified Person (Hybrid, Ireland)

Sanofi; Waterford; Hybrid; EUR 85,000 - 110,000; Full time

Benefits offered by this job

Disability Confident Employer

Inclusive interview process

Job summary

Sanofi in Waterford, Ireland, is seeking a Batch Release Lead Qualified Person to oversee end-to-end batch certification for sterile products. The role reports to the Head of Quality Lyo APU and involves leading quality initiatives, mentoring QA specialists, and ensuring timely release of products.

You will work onsite with a 3 days in the facility and 2 days remote per week, across a dynamic site expanding its capabilities.

Qualifications

• Has worked as a Qualified Person certifying and releasing batches on a manufacturing license, ideally in sterile product manufacturing.
• Familiar with current regulatory requirements for sterile manufacturing, including Annex 1, and engages in ongoing professional development.
• Strong communication skills with ability to influence across teams and drive quality outcomes.

Responsibilities

• Make sure all products released from the site meet strict quality and safety standards before they reach patients.
• Review and sign off on quality documents to confirm everything meets required standards.
• Work closely with other teams to resolve quality issues and close out actions in a timely manner.
• Investigate any product issues thoroughly, ensuring they’re fully resolved before release.
• Follow all safety procedures and speak up about safety concerns.
• Lead projects aimed at improving how quality processes work across the site.
• Support and mentor quality team members to grow their skills and expertise.

Skills

Qualified Person experience

Sterile manufacturing

Regulatory knowledge (Annex 1)

English fluency

Education

Master's degree in Pharmacy

Job description

Sanofi in Waterford, Ireland, is seeking a Batch Release Lead Qualified Person to oversee end-to-end batch certification for sterile products. The role reports to the Head of Quality Lyo APU and involves leading quality initiatives, mentoring QA specialists, and ensuring timely release of products.

You will work onsite with a 3 days in the facility and 2 days remote per week, across a dynamic site expanding its capabilities.