Senior Quality Assurance Officer

Position: Senior Quality Assurance Officer at Replimune
Location: Montreal

Replimune is seeking a Senior Quality Assurance Officer II in Milton Park to uphold the highest quality standards in cancer therapies. Make a significant impact on patient outcomes through your diligence.

In this pivotal role, you will manage the development and implementation of quality assurance systems, ensuring compliance with FDA and EMA guidelines. Your position includes performing batch reviews and collaborating closely with various teams to enhance quality systems and drive continuous improvement in GMP compliance. Your contributions will directly influence the integrity of drug products in clinical settings.

Key Responsibilities:

• Manage quality systems and batch review processes

• Support GMP compliance through thorough audits and corrective actions

• Author and approve quality documentation and SOPs

• Conduct trainings and performance assessments

• Report on quality metrics to improve governance

Requirements:

• Bachelor’s degree and a Master’s preferred

• 6+ years in quality roles within regulated industries

• Familiarity with GMP regulations and auditing processes

• Strong written and verbal communication skills

• Proficient in Microsoft Office applications

Join Replimune to leverage your quality assurance expertise in a transformative healthcare environment.
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