Senior Manager, Quality Control at Xenon

Join Xenon Pharmaceuticals as a Senior Manager, leading Quality Control for clinical and commercial drug programs. Drive quality oversight ensuring compliance with ICH and cGMP standards across all projects.

In this pivotal role, you will manage Quality Control activities for drug substance and drug product programs. The ideal candidate will bring strong expertise in analytical testing and stability programs, fostering collaboration across teams to resolve issues. You will work closely with external laboratories and internal stakeholders to ensure quality assurance is at the forefront of every project.

Key Responsibilities:

• Oversee analytical results for product release and stability

• Manage stability activities and data analysis

• Direct reference standard program at external labs

• Review specifications for materials and products

• Lead investigations for OOS and OOT results

Requirements:

• 5+ years management experience in pharmaceuticals

• Strong background in quality control and stability programs

• Experience with FDA/EMA inspections preferred

• Excellent communication and leadership skills

• Willingness to travel up to 20%

Drive critical quality functions and enhance drug development as part of Xenon’s cutting-edge neuroscience team.
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