Senior Manager/Associate Director, Quality Assurance, GCP

Scorpion Therapeutics; Boston (MA); Hybrid; USD 140,000 - 190,000; Full time

Job summary

Xenon Pharmaceuticals is seeking a Senior Manager/Associate Director, Quality Assurance to lead quality oversight for early-phase clinical studies. The role emphasizes GCP/GLP compliance, risk management, and collaboration with cross-functional teams to uphold high QA standards in a dynamic environment.

The successful candidate will develop Quality Plans, support regulatory inspections, and drive a robust audit program across GLP activities, with a focus on accelerating neuroscience therapeutics.

Qualifications

• Bachelor's degree in a scientific or health field required.
• 8+ years of GxP QA experience with emphasis on GCP.
• Strong leadership experience in pharma/biotech QA teams.
• Deep knowledge of GCP and GLP regulations; regulatory agency experience (FDA/EMA).
• Excellent audit and risk management skills.

Responsibilities

• Lead quality oversight for clinical studies as Quality lead.
• Develop and maintain Quality Plans for early-phase programs.
• Oversee risk assessments and ensure regulatory compliance (GCP/GLP).
• Support regulatory inspections and audit programs; oversee GLP activities.
• Collaborate with cross-functional teams to uphold quality standards.

Job description

Role

Senior Manager/Associate Director, Quality Assurance, GCP at Xenon Pharmaceuticals, supporting early-phase clinical programs (pre-Phase 3).

Responsibilities

serve as quality lead for clinical studies, develop and maintain Quality Plans, oversee risk assessments, and ensure compliance with GCP and GLP regulations; support regulatory inspections, audit programs, and quality oversight for GLP activities; collaborate with cross-functional teams to uphold quality standards.

Requirements

Bachelor's in a scientific or health field, 8+ years of GxP QA experience (6+ in GCP), at least 3 years in a leadership role within pharma or biotech; deep knowledge of GCP and GLP regulations, experience with regulatory agencies (FDA, EMA, etc.), and strong audit and risk management skills.

High Value

supporting early-stage clinical development, GCP/GLP compliance, clinical trial oversight, experience with regulatory inspections, preferably in neuroscience or neurotherapeutics.

Work Setup

hybrid Boston-based (Needham), remote considered for exceptional candidates; minimal travel required.