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