Manager, Quality Assurance – Good Clinical Practice, Auditor Strategy

Job Description:

• Guide and lead management of Good Clinical Practice Audit Strategy Programs
• Create strategic partnerships and direct risk-based audit activities
• Develop audit risk assessments and implement audit risk-based strategies
• Ensure audits are conducted in accordance with approved audit programs
• Maintain core study specific information for auditors
• Apply audit outcomes to identify quality trends and communicate compliance risks
• Represent on complex compliance projects
• Draft and issue periodic reports to management
• Provide education and/or training to Global Development departments

Requirements:

• Bachelor’s degree with 6+ years of industry experience
• 4+ years of direct GCP strategy or audit experience
• Experience with FDA or other Regulatory Inspections of Investigator sites, Sponsors or CROs
• Knowledge of the FDA and EU regulations and ICH guidance documents
• Strong track record of project management, collaborator management and negotiation of complex situations

Benefits:

• health and wellness programs (including medical, dental, vision, life, and disability insurance)
• fitness centers
• 401(k) company match
• family support benefits
• equity awards
• annual bonuses
• paid time off
• paid leaves (e.g., military and parental leave)