Senior QMS Specialist - Pre-IPO Biotech Career Growth

Orca Bio; United States; Remote; USD 90,000 - 120,000; Full time

Benefits offered by this job

Pre-IPO equity

Annual bonus

Benefits package

Job summary

Orca Bio is seeking a Senior Specialist, Global QMS to implement and scale the quality management system across sites, leading internal audits, supplier management, and inspection readiness. You will partner with cross‑functional teams to ensure GxP compliance and drive data‑driven quality improvements.

This remote‑friendly role offers a path from pre‑IPO to commercial readiness, with competitive compensation, pre‑IPO equity, and a comprehensive benefits package.

Qualifications

• Bachelor’s degree in a scientific or engineering discipline; advanced degree preferred.
• 5+ years QA/QMS in a GxP-regulated environment, with 2–3 years in a leadership role.
• Strong knowledge of FDA, EMA, ICH, ISO 9001, 21 CFR Parts 210/211/820, EU GMP.
• Experience leading internal audits, QMR, supplier management, and validation oversight.

Responsibilities

• Plan, schedule and execute internal audits across sites.
• Develop audit agendas, conduct interviews, review processes.
• Support the global Quality Management Review (QMR) process with data collection and reporting.
• Support the supplier qualification and management program with risk assessments and audits.
• Drive global inspection management activities for FDA, EMA inspections.
• Provide oversight to site QMR administrators for consistent QMS implementation.
• Establish and monitor global QMS KPIs and quality metrics.
• Collaborate with IT to implement QMS enhancements and validate changes.
• Review and approve validation documents for enterprise systems.

Skills

QMS governance

Inspection readiness

System validation

Quality metrics KPIs

Cross-functional leadership

Education

Bachelor's degree in science/engineering

Tools

MasterControl

TrackWise

ERP systems

Job description

Senior QMS Specialist - Pre-IPO Biotech Career Growth — Remote

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 (MasterControl, 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.

Responsibilities

• 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 other health authority inspections.
• Provide oversight and guidance to site QMR administrators ensuring consistent quality system implementation across all Orca Bio sites.
• Establish and monitor global QMS key performance indicators (KPIs), oversee trending of quality metrics, and ensure data-driven insights are used to improve quality systems and performance.
• Partner with IT and business process owners to identify and implement QMS system enhancements, including defining requirements, driving prioritization and ensuring changes are validated and compliant.
• Review, approve, and provide quality oversight for validation documentation (e.g., equipment qualification, computer system validation, process validation) for global enterprise systems (e.g. MasterControl, ERP systems, Trackwise, etc.) ensuring alignment with regulatory and internal requirements.
• Collaborate with cross-functional and site leadership teams to drive continuous improvement initiatives, ensuring the QMS evolves in line with business needs and regulatory expectations.

Experience

• Bachelor’s degree in a scientific or engineering discipline required; advanced degree preferred.
• Minimum 5+ years of relevant Quality Assurance or Quality Systems experience in a GxP-regulated environment, with at least 2-3 years in a leadership role.
• Strong knowledge of global quality regulations and standards (FDA, EMA, ICH, ISO 9001, 21 CFR Parts 210/211/820, EU GMP).
• Proven experience leading Quality Management Review, internal audit programs, supplier management processes, and validation oversight.
• Demonstrated success in establishing and trending quality performance metrics and KPIs.
• Experience supporting and/or administering electronic QMS systems and partnering with IT for system enhancements.
• Experience working in a multi-site or global quality organization strongly preferred.
• Excellent organizational, analytical, and communication skills, with the ability to influence and collaborate across functional and site boundaries.

Compensation: $90,000 – $120,000 per year

The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.

Who we are

We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.

We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.

We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask "why not" and challenge the status quo.

We maintain a start-up culture of camaraderie and leadership by example, regardless of title.

We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.

Remote work & career advice that actually works.

Is the Senior Specialist, Global QMS role at Orca Bio fully remote? The posting indicates remote-based positions are possible, but the role involves conducting on-site internal audits across multiple manufacturing sites and supporting FDA/EMA inspections, which requires significant in-person presence. Candidates should confirm the exact hybrid or remote arrangement before applying. What is the salary range for this position? The anticipated annual salary range is $90,000–$120,000, with variation based on location, experience, and education. Full-time employees also receive pre-IPO equity, an annual bonus, and a comprehensive benefits package. What qualifications are required for this QMS role? A Bachelor’s degree in a scientific or engineering discipline is required (advanced degree preferred), along with 5+ years of QA or Quality Systems experience in a GxP-regulated environment, including at least 2–3 years in a leadership role. What quality systems and tools will I work with in this role? The role involves working with enterprise QMS platforms such as MasterControl and Trackwise, as well as ERP systems. You’ll provide quality oversight for computer system validation and partner with IT for system enhancements. Does Orca Bio offer equity compensation? Yes, full-time employees are eligible to receive pre-IPO equity in addition to an annual bonus, making this an attractive opportunity for candidates interested in sharing in the company’s potential future growth.