The Role
Owns administration, implementation, integration, roadmap, security, compliance, and support for Orca Bio’s business systems portfolio. The role supports Salesforce-based chain-of-custody and chain-of-identity platforms, drives AI and automation adoption, manages development partners, leads a small systems team, and coordinates validation for regulated systems. Responsibilities include stakeholder requirements gathering, IT assessments, release planning, documentation, audit readiness, and compliance with GxP, 21 CFR Part 11, HIPAA, and security frameworks.
Summary Generated by Built In
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.
Orca Bio is seeking a hands-on Manager/Senior Manager, Business Systems to own the day-to-day administration, implementation, and roadmap of our business systems portfolio, with a strong focus on AI applications and supporting OrcaLink – Orca Bio’s Salesforce-based Chain of Custody / Chain of Identity (COC/COI) platform. Reporting to the Head of Business Systems and Architecture, this person will help manage our contracted software development teams, partner closely with business stakeholders across the company, and ensure our regulated and non-regulated systems are secure, compliant, scalable, and increasingly powered by AI and automation.
Essential Duties & Key Responsibilities
- Manage the full lifecycle of business systems requests – intake, requirements, configuration/build, testing, deployment, and post-launch support across Orca Bio’s platforms.
- Evaluate, implement, and integrate new business applications (CRM, ERP, QMS, MES, CTMS, HRIS, and similar) as Orca Bio’s commercial and enterprise footprint grows.
- Partner cross-functionally with business stakeholders and SMEs to translate business needs into scalable systems solutions.
- Support OrcaLink (our Salesforce-based COC/COI platform) in partnership with the OrcaLink platform owner and Salesforce administrators, contributing to configuration, release planning, and roadmap priorities as needed.
- Lead and complete IT assessments for OrcaLink in partnership with the internal Security team – evaluating site infrastructure, access controls, and data-handling practices, and tracking remediation to enable secure onboarding and ongoing connectivity.
- Identify, scope, and drive adoption of AI applications and automation across the business, prioritizing use cases that improve operations and reduce manual effort.
- Serve as the primary bridge between business stakeholders and the development team on AI and platform initiatives.
- Lead, mentor, and grow a small team of business systems analysts/administrators supporting commercial and enterprise systems.
- Support Computer System Validation (CSV) activities for GxP-regulated systems, including validation protocols and change control (QCCR), partnering closely with Quality and Validation teams.
- Ensure business systems comply with GxP, 21 CFR Part 11, HIPAA, and related security frameworks (ISO 27001, SOC 2, NIST) as applicable.
- Maintain systems documentation, integration architecture diagrams, and SOPs/work instructions for owned platforms.
Minimum Experience, Education, Certifications, Licenses
- Bachelor’s degree in Computer Science, Information Systems, Business, or a related field, or equivalent experience.
- 5-8+ years of experience in business systems, IT applications, or systems administration, including 3-5 years in a regulated life sciences/biotech environment.
- Experience implementing, integrating, and administering enterprise/commercial platforms (CRM, ERP, QMS, MES, CTMS, or similar).
- Hands-on experience scoping and delivering AI applications and automation, with a track record of translating business needs into requirements for technical teams and improving operational efficiency.
- Working knowledge of GxP requirements, 21 CFR Part 11, and Computer System Validation (CSV) practices.
- Experience managing or mentoring a team, or leading cross-functional project teams.
- Strong understanding of data security, access control, and audit-readiness practices.
- Excellent communication skills, with the ability to translate technical concepts for non-technical stakeholders.
Preferred Qualifications
- Direct experience supporting a Salesforce-based patient services, commercial, or chain-of-custody platform.
- Hands-on Salesforce administration experience.
- Familiarity with the following systems/platforms: Salesforce, AWS, TrakSYS, NetSuite, MasterControl, and Veeva.
- Experience with SOX, GDPR, ISO 27001, or NIST frameworks.
- Experience in cell and gene therapy or another regulated commercial/clinical setting.
- Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)
- Data Integrity (ALCOA+ principles)
- 21 CFR Part 11 and Computer System Validation (CSV)
- Quality Management System (QMS) training, including Change Control (QCCR), CAPA, Deviations, and Document Control
- FDA inspection readiness and regulatory compliance
- Company SOPs, policies, and applicable quality procedures
- Information security, cybersecurity, HIPAA, and confidentiality training
- Safety and Environmental Health & Safety (EHS) training applicable to office and manufacturing environments
- Occasional travel between Orca Bio sites (Menlo Park and Sacramento) and limited domestic travel as needed (approximately [0-10]%).
Training & Continuous Improvement:
Mandatory training will be assigned on a regular basis, and as needed. You are expected to complete all assigned training by the due date.
Travel Requirements
The anticipated annual salary range (listed above) 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.
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.
Skills Required
- Bachelor's degree in Computer Science, Information Systems, Business, or a related field, or equivalent experience
- 5-8+ years of experience in business systems, IT applications, or systems administration
- 3-5 years of experience in a regulated life sciences or biotech environment
- Experience implementing, integrating, and administering enterprise or commercial platforms such as CRM, ERP, QMS, MES, or CTMS
- Hands-on experience scoping and delivering AI applications and automation
- Experience translating business needs into requirements for technical teams
- Working knowledge of GxP requirements, 21 CFR Part 11, and Computer System Validation practices
- Experience managing or mentoring a team, or leading cross-functional project teams
- Strong understanding of data security, access control, and audit-readiness practices
- Excellent communication skills and ability to explain technical concepts to nontechnical stakeholders
- Experience supporting a Salesforce-based patient services, commercial, or chain-of-custody platform
- Hands-on Salesforce administration experience
- Familiarity with Salesforce, AWS, TrakSYS, NetSuite, MasterControl, and Veeva
- Experience with SOX, GDPR, ISO 27001, or NIST frameworks
- Experience in cell and gene therapy or another regulated commercial or clinical setting
Am I A Good Fit?
Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.
Success! Refresh the page to see how your skills align with this role.
The Company
What We Do
Orca Bio is a clinical-stage biotechnology company developing a pipeline of high precision allogeneic cell therapy products that are designed to safely replace patients’ diseased blood and immune system with a healthy one. Our manufacturing platform sorts donor blood with single-cell precision and a high level of purity and speed, enabling us to create proprietary, optimal therapeutic mixtures of immune and stem cells that have the potential to transform allogeneic cell therapy. Our talented team is driven by a passion for science and compassion for patients.
