Senior Manager of Clinical Quality Assurance - Remote

Overview

The Sr. Manager of Clinical QA is responsible for ensuring the quality and clinical compliance of operations with corporate policies, industry standards, and applicable regulations. This role provides expertise and guidance on Good Clinical Practice (GCP) and applicable regulations to clinical development teams to proactively identify compliance issues/risks and recommend mitigation.

In Short

• Provide expertise in GCP and compliance interpretation.
• Support Clinical Operations in designing a risk-based quality management framework.
• Assist study teams in root cause analysis of deviations.
• Participate in review of emerging regulations for compliance.
• Maintain and improve quality assurance strategies.
• Support inspection readiness activities.
• Participate in due diligence and process improvement initiatives.

Requirements

• Bachelor's degree in Life Sciences.
• 7+ years in pharmaceutical or biotechnology drug development.
• 5 years in a GCP compliance/quality role.
• Strong knowledge of regulatory guidelines (ICH, FDA, EMA).
• Experience with global clinical research studies.
• Auditing experience and GCP Certification desired.
• Exceptional understanding of ICH GCP requirements.
• Experience in negotiating and managing CROs.
• Experience with CSV procedures, EDC, and ePRO systems.
• Ability to work in an Agile environment.

Benefits

• 99% premium cost covered for medical, dental, and vision plans.
• Quarterly bonus program.
• 401k plan with 100% match up to 6%.
• Wellness benefit of $200/month.
• Unlimited PTO and generous family leave.
• Eligibility for equity awards and Employee Stock Purchase Plan.