QA Operations Leader: Batch Review & Compliance

Regeneron Pharmaceuticals, Inc; Munster; On-site; EUR 74,000 - 141,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. in Raheen, Limerick is seeking a Manager / Sr Manager QA Operations for the QA Operations Batch Review team.

You will lead and oversee QA Operations processes, ensuring compliance with regulatory standards and internal requirements to drive quality and efficiency. The role requires 8+ years (8+ years for base role; 10+ for Senior Manager) of pharma/biologics manufacturing experience and a strong track record in leadership and cross-functional collaboration.

Qualifications

• BSc/BEng in scientific discipline or related field with 8+ years’ experience in a pharmaceutical/biologics manufacturing environment.
• Sr Manager: BSc/BEng plus 10+ years' experience.

Responsibilities

• Direct QA Operations processes to ensure performance and quality conform to regulatory standards and internal requirements.
• Drive initiatives to improve processes, reduce waste and increase efficiency.
• Provide leadership and collaboration across the organization at all levels.
• Partner with US counterparts for global alignment of processes and systems.
• Identify risks and implement mitigations in operations.
• Ensure resourcing for document schedules and budgeting for headcount and operating costs.
• Define and implement quality standards, systems, and metrics for QA Operations.
• Report process performance with timely, accurate metrics for leadership.
• Provide site support for QA Operations global projects and initiatives.

Skills

QA Operations

Regulatory compliance

Leadership

Cross-functional collaboration

Education

BSc/BEng in scientific discipline

Job description

Regeneron Pharmaceuticals, Inc. in Raheen, Limerick is seeking a Manager / Sr Manager QA Operations for the QA Operations Batch Review team.

You will lead and oversee QA Operations processes, ensuring compliance with regulatory standards and internal requirements to drive quality and efficiency. The role requires 8+ years (8+ years for base role; 10+ for Senior Manager) of pharma/biologics manufacturing experience and a strong track record in leadership and cross-functional collaboration.