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 late-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 investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
Summary of Role: We are seeking a hands-on Head of Systems Architecture to lead the design, integration, and governance of both enterprise and GxP-regulated systems across our organization. This individual will be deeply involved in building and scaling a pragmatic technology ecosystem that supports core business functions, including Quality, Manufacturing, Clinical, ERP, CRM, and Finance, while ensuring systems are scalable, compliant, and tightly aligned with evolving business needs.
This role is ideal for someone who thrives in high-growth, dynamic environments and prefers practical, fit-for-purpose solutions over heavyweight enterprise platforms by default. The architecture will blend in-house built tools with tailored off-the-shelf systems, selected based on company stage, internal capabilities, and delivery timelines. It is a high-impact, execution-heavy leadership role with significant influence over the company’s technology stack, systems roadmap, data governance, and long-term scalability.
Key Responsibilities
- Act as the company’s technical lead and architect across enterprise and GxP-regulated systems.
- Design and implement an end-to-end systems architecture that is modular, scalable, and adaptable to evolving regulatory and operational requirements.
- Develop and maintain the enterprise architecture blueprint, including system diagrams, integration points, data flows, and process workflows.
- Drive the evaluation, selection, customization, and deployment of systems, including QMS, MES, LIMS, CTMS, ERP, CRM, and Financials, favoring lean, adaptable tools that match current company scale.
- Build and integrate custom in-house solutions where appropriate, ensuring seamless interaction with off-the-shelf systems
- Ensure tight integration between regulated (GxP) and non-regulated systems to support business continuity, data integrity, and audit-readiness.
- Define and enforce best practices for data lifecycle management, access controls, system validation, and audit preparedness in accordance with regulatory requirements.
- Oversee adherence to regulatory and security frameworks including GxP, 21 CFR Part 11, SOX, GDPR, ISO 27001, and NIST.
- Lead agile, iterative implementation cycles, balancing rapid delivery with validation, quality, and documentation requirements.
- Build and mentor a small, high-performance team of developers and engineers focused on secure, compliant, and scalable system delivery.
Preferred Education and Experience
- Bachelor’s or Master’s degree in computer science, Information Systems, Engineering, or a related field.
- 10+ years of experience in systems architecture, with at least 8 years in a regulated life sciences environment (e.g., quality, lab, clinical, or manufacturing).
- Direct experience designing and operating systems in compliance with GxP regulations, 21 CFR Part 11, SOX and GDPR.
- Familiarity with security and compliance frameworks such as NIST, ISO 27001, and risk-based validation approaches.
- Deep understanding of GxP systems (E.g., MES, QMS, LIMS, CTMS) and enterprise platforms (E.g., CRM, ERP, Financials)
- Experience delivering and integrating in-house tools with commercial systems, ideally in a growth-stage environment.
- Hands-on experience or technical fluency with AWS, Salesforce, Trasksys, and related cloud-based platforms is preferred.
Required Skills
- Strong track record in hands-on system design, integration, and implementation.
- Experience scaling infrastructure and systems in startup or high-growth biotech/pharma environments.
- Ability to operate at strategic and tactical levels, from roadmap development to detailed execution.
- Expertise in agile development, DevOps, and CI/CD practices.
- Deep knowledge of enterprise SaaS, cloud infrastructure, and hybrid environments.
- Excellent communication and collaboration skills across engineering, quality, regulatory, and business teams.
- Strong analytical and problem-solving capabilities, with a focus on practical, sustainable solutions.
- Demonstrated success in building and managing high performance technical teams.
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. You will also be eligible to receive pre-IPO equity, in addition to medical, dental, and vision benefits, flexible PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include free 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.
Notice to staffing firms
Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
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