Manager / Senior Manager, Business Systems

Orca Bio•Sacramento, CA

About The Position

Orca Bio is seeking a hands-on Manager/Senior Manager, Business Systems to own day-to-day administration, implementation, and roadmap planning for its business systems portfolio, with a strong focus on AI applications and OrcaLink, the company’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 spans the full lifecycle of business systems requests, implementation and integration of enterprise applications, support of OrcaLink, and assessment of security and site infrastructure for OrcaLink onboarding and connectivity. The position will also identify and drive AI and automation initiatives, lead a small team of business systems analysts/administrators, and support Computer System Validation (CSV) for GxP-regulated systems in partnership with Quality and Validation teams. The role maintains system documentation, integration architecture diagrams, and SOPs/work instructions while ensuring applicable regulatory and security requirements are met. Mandatory training is assigned regularly and as needed, and must be completed by its due date. Training includes cGMP and GDP, ALCOA+ data integrity, 21 CFR Part 11 and CSV, QMS procedures including QCCR, CAPA, deviations and document control, FDA inspection readiness, company SOPs, information security, cybersecurity, HIPAA, confidentiality, and applicable EHS training. 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, CTMS, or similar.
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 across Orca Bio platforms.
Evaluate, implement, and integrate business applications such as CRM, ERP, QMS, MES, CTMS, and HRIS as the company grows.
Partner with business stakeholders and subject-matter experts to translate business needs into scalable systems solutions.
Support OrcaLink with its platform owner and Salesforce administrators, contributing to configuration, release planning, and roadmap priorities as needed.
Lead IT assessments for OrcaLink 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 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 applicable GxP, 21 CFR Part 11, HIPAA, ISO 27001, SOC 2, NIST, and related requirements.
Maintain systems documentation, integration architecture diagrams, and SOPs/work instructions for owned platforms.
Complete all assigned mandatory training by its due date.
Travel occasionally between Menlo Park and Sacramento sites and undertake limited domestic travel as needed.