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Orca Bio is a commercial-stage biotechnology company developing next-generation cell therapies for blood cancer treatment. The company is seeking a hands-on Manager/Senior Manager of Business Systems to own the day-to-day administration, implementation, and strategic roadmap of the 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 role will manage contracted software development teams, partner closely with business stakeholders across the company, and ensure regulated and non-regulated systems are secure, compliant, scalable, and increasingly powered by AI and automation.
Key responsibilities include:
- Managing the full lifecycle of business systems requests (intake, requirements, configuration, testing, deployment, post-launch support) across platforms
- Evaluating, implementing, and integrating new business applications (CRM, ERP, QMS, MES, CTMS, HRIS) as the company scales
- Partnering cross-functionally with business stakeholders and subject matter experts to translate business needs into scalable systems solutions
- Supporting OrcaLink in partnership with the platform owner and Salesforce administrators, contributing to configuration, release planning, and roadmap priorities
- Leading IT assessments for OrcaLink in partnership with the internal Security team, evaluating site infrastructure, access controls, and data-handling practices
- Identifying, scoping, and driving adoption of AI applications and automation across the business
- Serving as the primary bridge between business stakeholders and development teams on AI and platform initiatives
- Leading, mentoring, and growing a small team of business systems analysts and administrators
- Supporting Computer System Validation (CSV) activities for GxP-regulated systems, including validation protocols and change control
- Ensuring business systems comply with GxP, 21 CFR Part 11, HIPAA, and related security frameworks (ISO 27001, SOC 2, NIST)
- Maintaining systems documentation, integration architecture diagrams, and SOPs/work instructions
Travel: Occasional travel between Orca Bio sites (Menlo Park and Sacramento) and limited domestic travel as needed (approximately 0-10%).
Requirements:
- Bachelor's degree in Computer Science, Information Systems, Business, or 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 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
