Orca Bio is hiring a Manager, Quality – Commercial Site Onboarding (West Coast) to lead quality assurance efforts for launching new commercial sites. This remote role within the Quality Assurance department is pivotal for ensuring compliance and operational readiness as we expand our commercial footprint.
What You'll Do
- Lead quality oversight and compliance activities for new commercial site onboarding on the West Coast.
- Develop and execute quality plans, risk assessments, and documentation strategies for site launch.
- Partner with commercial and operational teams to ensure sites meet all regulatory and quality standards.
- Manage audit readiness and support inspections for newly onboarded sites.
- Provide quality training and guidance to site personnel.
What We're Looking For
- Proven experience in a Quality Assurance role within a regulated life sciences environment.
- Direct experience with commercial site onboarding, activation, or quality systems implementation.
- Strong knowledge of FDA, cGMP, and other relevant regulatory requirements.
- Excellent project management and cross-functional collaboration skills.
- Ability to work independently and make sound quality decisions in a remote setting.
Work Mode
This is a fully remote position for candidates located on the West Coast of the United States.
Orca Bio is an equal opportunity employer.
