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.
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.
- 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
Travel Requirements
- Occasional travel between Orca Bio sites (Menlo Park and Sacramento) and limited domestic travel as needed (approximately [0-10]%).
