Remote-Eligible Batch Release Lead, QA & Compliance

Sanofi; Munster; Hybrid; EUR 95,000 - 125,000; Full time

Job summary

Sanofi Waterford site seeks a Batch Release Lead Qualified Person to oversee production release in sterile manufacturing, ensuring cGMP compliance and timely batch certification. Reporting directly to the Head of Quality Lyo APU, you will sign off on quality documents and mentor QA specialists.

Role requires on-site work with a flexible 3 days onsite, 2 days remote pattern, English fluency, and Ireland-based eligibility. Join a team delivering world-class medicines.

Qualifications

• Qualified Person status with ability to certify and release batches.
• Familiar with sterile manufacturing and Annex 1 regulatory requirements.
• Strong communication skills and results-driven mindset.

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, making sure they're fully resolved before a product is released.
• Follow all safety procedures carefully and speak up if you notice any safety concerns.
• Lead projects aimed at improving how quality processes work across the site.
• Support and guide quality team members, helping them grow their skills and expertise.

Skills

Strong communicator

Results-driven

Education

Master's degree or Pharmacy qualification

Job description

Sanofi Waterford site seeks a Batch Release Lead Qualified Person to oversee production release in sterile manufacturing, ensuring cGMP compliance and timely batch certification. Reporting directly to the Head of Quality Lyo APU, you will sign off on quality documents and mentor QA specialists.

Role requires on-site work with a flexible 3 days onsite, 2 days remote pattern, English fluency, and Ireland-based eligibility. Join a team delivering world-class medicines.