Clinical QA Manager/Sr. Manager

Seattle, WA – We're partnering with a rapidly growing biotechnology company that combines the stability of a commercial-stage organization with the excitement of a broad and expanding clinical pipeline. With multiple programs advancing across rare disease, immunology, oncology, and other high-impact therapeutic areas, this is a chance to gain exposure to a diverse portfolio that few biotech companies can offer.

About the Role

As Clinical QA Manager/Senior Manager, you'll provide quality oversight across clinical development activities, ensuring studies are conducted in compliance with GCP requirements and industry best practices. You'll act as a strategic quality partner, supporting clinical teams, CRO oversight, audit programs, inspection readiness activities, CAPA management, and continuous improvement initiatives across a growing portfolio of programs.

This is an ideal opportunity for someone who enjoys being close to the science, influencing decision-making, and helping build a quality organization capable of supporting substantial future growth.

Why Join

• Multiple clinical and commercial-stage assets creating long-term stability
• Broad pipeline offering exposure across numerous studies, vendors, and development programs
• Opportunity to influence quality strategy across an expanding organization
• Visible role working directly with senior leaders and cross-functional teams
• Significant potential for career progression as the company continues to grow
• Equity, bonus, and strong total compensation package
• Chance to make a tangible impact rather than being a small part of a much larger organization

Requirements

• Bachelor's degree in a scientific discipline
• 8+ years of Clinical QA experience within biotech, pharma, or CRO environments
• Strong GCP knowledge with hands-on auditing experience
• Experience managing audits, CAPAs, investigations, and vendor oversight
• Ability to partner effectively with Clinical Operations, Regulatory, and executive stakeholders
• Strong communication, problem-solving, and leadership skills

Benefits

• Equity
• Bonus
• Strong total compensation package