Hybrid Senior Director, Head of GCP Quality Assurance

at Nkarta, Inc.

• Job title: Senior Director, Head of GCP Quality Assurance
• Job type: Full Time
• Experience level: Senior
• Salary: $250,000 - $340,000 per year
• Degree requirement: Bachelor's Degree
• Tech skills: Google Cloud Platform
• Location requirements: Hybrid, South San Francisco, United States

About the role

• Senior Director overseeing GCP Quality Assurance activities at Nkarta, a biotech focusing on cellular therapies. Ensuring high quality execution of clinical trials for cell therapy drug candidates.

Responsibilities

• Proactively provide GCP QA support for clinical development activities to protect patient safety & wellbeing, maintain data integrity, and support operational excellence
• Independently conduct Clinical Investigator Site Audits, GCP Document Audits (Clinical Study Reports and Trial Master Files), internal Process Audits and support Vendor/System audits
• Author and manage Audit Plans and Audit reports
• Facilitate ongoing quality improvement through communication of audit results, CAPAs and GCP guidance and consultation to clinical teams
• Manage health authority inspection preparation activities and provide leadership and oversight during inspections
• Review and provide input to clinical documentation (e.g. protocols, study reports, IBs, ICFs, etc.)
• Compile and analyze audit metrics to communicate trends to business groups
• Maintains a high level of expertise in GCP drug development regulations, ICH guidelines and internal policies and procedures that may impact drug development.
• Conduct GCP training sessions for business groups
• Build out the GCP function to support pivotal readiness
• Manage direct reports (if applicable)

Requirements

• Bachelor’s degree in science-related discipline; advanced degree preferred
• Preferably 15+ years’ experience in Clinical research/operations/data management or related area
• Minimum of 8 years of Clinical Quality Assurance auditing
• Direct/lead experience with FDA, EMA, MHRA, PMDA, or other health authority inspections of sponsor, investigator site(s), and/or CRO(s)
• Fundamental knowledge of US, EU and APAC international regulatory standards and guidelines for the conduct of clinical trials
• Strong analytical skills and report writing skills
• Self-motivated with ability to take initiative, ownership and manage multiple responsibilities while shifting priorities quickly under tight timelines
• Excellent teamwork skills with the ability to develop and maintain positive, collaborative relationships with colleagues at all levels across the organization.
• Must have professional communications skills, strong independent time management skills and the ability to manage multiple projects concurrently
• Experience with supervising direct reports preferred

Benefits

• Medical, dental, vision, and life insurance coverage
• 401K plan
• Flexible spending account
• ESPP
• Employee assistance program
• Paid vacation, holiday, and personal days
• Paid parental, pregnancy, and bereavement leave