Director, GMP Quality Assurance Boston

Step into a pivotal role at Xenon Pharmaceuticals as Director of Quality Assurance, GMP, specializing in clinical program oversight. This position offers strategic impact in a hybrid work setting.

Xenon aims to enhance its Quality GMP team with a Director who will lead vital quality assurance processes for therapeutic drugs in development. This role facilitates collaboration across R&D, Manufacturing, and Quality teams, demanding an extensive background in cGMP compliance and quality systems. You will play a key role in shaping the quality culture within the organization.

Key Responsibilities:

• Direct quality assurance for clinical manufacturing sites

• Oversee external quality processes and compliance matters

• Contribute to CMC discussions and quality reviews

• Author quality agreements and system documentation

• Represent Quality in project and inspection meetings

Requirements:

• Bachelor’s degree in life sciences and 10+ years in quality

• Expertise in small molecule drug production

• Strong understanding of global GxP standards

• History of effective team and project management

• Excellent organizational and communication skills

Lead quality initiatives and influence advancements in neuroscience at Xenon.
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