Manager / Senior Manager, Business Systems

Orca Bio•Sacramento, CA

10d•$140,000 - $180,000

About The Position

Orca Bio is seeking a hands-on Manager/Senior Manager, Business Systems to own the day-to-day administration, implementation, and roadmap of its business systems portfolio, with a strong focus on AI applications and support for 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 contracted software development teams, partner with business stakeholders across the company, and ensure regulated and non-regulated systems are secure, compliant, scalable, and increasingly powered by AI and automation. The role manages the full lifecycle of business systems requests and supports evaluation, implementation, integration, and administration of business applications as Orca Bio grows. It also supports OrcaLink configuration, release planning, roadmap priorities, and IT assessments for secure site onboarding and ongoing connectivity. The position identifies and drives AI and automation adoption, serves as a bridge between stakeholders and development teams, and leads a small team of business systems analysts/administrators. The role supports Computer System Validation (CSV) for GxP-regulated systems and helps ensure compliance with GxP, 21 CFR Part 11, HIPAA, and applicable security frameworks. It maintains documentation, integration architecture diagrams, SOPs, and work instructions. Occasional travel between Orca Bio sites in Menlo Park and Sacramento and limited domestic travel may be required, approximately 0–10%.

Requirements

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 or commercial platforms such as CRM, ERP, QMS, MES, or CTMS.
Hands-on experience scoping and delivering AI applications and automation, 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 and ability to translate technical concepts for non-technical stakeholders.

Nice To Haves

Direct 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/clinical setting.

Responsibilities

Manage the full lifecycle of business systems requests, including intake, requirements, configuration/build, testing, deployment, and post-launch support.
Evaluate, implement, and integrate new business applications, such as CRM, ERP, QMS, MES, CTMS, and HRIS platforms.
Partner with business stakeholders and subject-matter experts to translate business needs into scalable systems solutions.
Support OrcaLink alongside its platform owner and Salesforce administrators, contributing to configuration, release planning, and roadmap priorities as needed.
Lead IT assessments for OrcaLink in partnership with the internal Security team, evaluating site infrastructure, access controls, and data-handling practices and tracking remediation for secure onboarding and ongoing connectivity.
Identify, scope, and drive adoption of AI applications and automation, 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 CSV activities for GxP-regulated systems, including validation protocols and change control (QCCR), in partnership with Quality and Validation teams.
Ensure business systems comply with GxP, 21 CFR Part 11, HIPAA, and applicable security frameworks such as ISO 27001, SOC 2, and NIST.
Maintain systems documentation, integration architecture diagrams, and SOPs/work instructions for owned platforms.
Complete assigned training by its due date, including required quality, regulatory, security, safety, and company-procedure training.