Senior QMS Specialist - Pre-IPO Biotech Career

This is a Senior Specialist role at a commercial-stage, pre-IPO biotech — a compelling career moment. Orca Bio is transitioning from clinical to commercial manufacturing, meaning the QMS infrastructure you help build will directly shape the company's regulatory trajectory. Early commercial-stage experience at a biotech is highly valued and transferable.

Compensation context: The $90,000–$120,000 range is on the lower end for senior QA roles in biotech, where market rates for equivalent experience typically range from $110,000–$145,000 in major biotech hubs (San Francisco Bay Area, Boston). However, the pre-IPO equity component could significantly increase total compensation if Orca Bio achieves a successful public offering or acquisition.

• Multi-site global QMS governance — highly sought after in large pharma and CDMO organizations
• FDA and EMA inspection readiness — a top-tier, marketable competency
• Enterprise system validation (Master Control, Trackwise, ERP) — bridges QA and IT, expanding your scope
• KPI design and quality metrics trending — increasingly important as QA moves toward data-driven models

Green flags: Startup culture with real leadership exposure, cross-functional collaboration, and the opportunity to build programs from the ground up rather than maintain legacy systems. The cell therapy space is one of the fastest-growing in biopharma.

Watch for: The salary range suggests budget consciousness. Candidates should negotiate firmly, especially if bringing GMP cell therapy or ATMP experience. Confirm remote vs. hybrid expectations before accepting.

More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a commercial-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.

With our purified, high-precision cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.

The Senior Specialist, Global QMS will help implement Orca Bio’s global quality management system across all sites. This role will support and lead the internal audit program, supplier management program, and inspection readiness. This role will support the growth and expansion of the global quality program to support manufacturing of our cell therapy products. You will help establish, implement and maintain the audit program across Orca Bio sites to ensure compliance with GxP and regulatory expectations.

Your role will support Orca Bio’s commercial readiness and ongoing clinical programs by managing and facilitating audits, resolving supplier-related quality issues and interacting with quality management teams at the site levels to ensure consistent application of quality systems across the organization.

• Plan, schedule and execute internal audits across all sites and functions in accordance with the internal audit program.
• Develop audit agenda, conduct interviews, review processes and generate audit reports.
• Support the global Quality Management Review (QMR) process, ensuring timely data collection, analysis, and reporting to senior leadership.
• Support the supplier qualification and management program, including risk assessments, supplier audits, and ongoing monitoring to ensure compliance with GxP requirements.
• Drive global inspection management activities, ensuring cross-functional and site readiness for FDA, EMA, and…