Manager/Sr. Manager, GCP QA

Manager / Senior Manager, Clinical Quality Assurance

Location: Seattle, WA (Hybrid, can offer relocation package)

Overview

EPM Scientific is partnered with a growing biotechnology company to hire a Manager / Senior Manager, Clinical Quality Assurance. Our client is seeking a quality professional to provide oversight of global clinical development activities and ensure compliance with GCP regulations, internal procedures, and industry standards. This role will work closely with Clinical Operations and external partners to support quality initiatives, inspection readiness, auditing activities, and continuous improvement efforts across the clinical organization.

Key Responsibilities

• Provide quality and compliance oversight for clinical development activities
• Support quality strategy and planning for clinical programs
• Participate in the qualification, oversight, and evaluation of CROs and other service providers
• Conduct and support internal and external GCP audits of clinical trial activities
• Communicate audit findings and oversee CAPA development, implementation, and follow-up activities
• Partner with cross-functional teams to investigate and resolve quality and compliance issues
• Perform root cause investigations, trend analyses, and quality metrics reporting
• Provide guidance on GCP regulations, risk-based quality management, and industry best practices
• Draft, review, and revise SOPs and quality procedures
• Support development and delivery of GCP training programs
• Assist with regulatory inspection preparation, coordination, and management

Requirements

• Bachelor's degree in a scientific discipline
• 8+ years of Clinical Quality Assurance experience within pharmaceutical or biotechnology environments
• Minimum 3 years of GCP auditing experience
• Strong knowledge of GCP, GLP, ICH guidelines, and clinical regulatory requirements
• Experience managing CAPAs, quality investigations, and vendor oversight activities
• Excellent organizational, communication, and stakeholder management skills
• Ability to work independently and collaboratively in a fast-paced environment
• Strong analytical, problem-solving, and decision-making abilities
• Willingness to travel approximately 25-35%