Ensure the Company’s quality systems and activities are actively managed
Manage internal and external GLP/GCP audit programs and activities
Provide GLP/GCP compliance interpretation, consultation, training, and other services
Identify and escalate critical quality issues appropriately
Collaborate with internal departments to implement quality principles
Lead and manage GLP/GCP inspection readiness activities
Participate in regulatory inspections as needed
Recruit, lead, direct, develop, coach and evaluate direct reports

Bachelor’s degree in a scientific or health field
At least 10 years of GxP QA experience
8+ years GCP QA experience, supporting both development and commercial programs
Minimum of 5 years management level experience in pharma or biotech
Contemporary knowledge of GLP/GCP/GVP regulations
Experience interacting with regulatory inspectorates (FDA, Health Canada, EMA, MHRA)
Sound understanding of all phases of the drug development process
Experience in conducting audits and evaluating trends
Ability to prioritize work and manage complex projects
Proficient people management skills including mentorship, negotiation, and conflict resolution

Director, Quality Assurance, GCP

Key skills