AI-Driven Business Systems Manager (Biotech)

Orca Bio; Sacramento (CA); Presencial; USD 140.000 - 180.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Pre-IPO equity

Annual bonus

Medical, dental, vision benefits

PTO

401(k)

Life and disability insurance

Parental leave

Subsidized lunches

Descripción de la vacante

Orca Bio is seeking a hands-on Manager/Senior Manager, Business Systems to own daily administration, implementation, and roadmap across CRM, ERP, QMS, MES, CTMS, and HRIS platforms. You will partner with stakeholders, manage contracted development teams, and ensure systems are secure, compliant, and increasingly powered by AI.

You will lead a small team of analysts/administrators, support CSV activities, and ensure GxP, 21 CFR Part 11, HIPAA, and ISO 27001 compliance.

Formación

• Bachelor’s degree or equivalent experience in a relevant field.
• 5–8+ years in business systems or IT in regulated life sciences.
• Experience implementing enterprise platforms (CRM, ERP, QMS, MES, CTMS or similar).
• Hands-on AI applications and automation experience translating needs to technical teams.
• Working knowledge of GxP, 21 CFR Part 11, CSV practices.
• Experience mentoring teams and cross-functional leadership.
• Strong data security and audit-readiness understanding.
• Excellent written and verbal communication for non-technical stakeholders.

Responsabilidades

• Own day-to-day admin, implementation, and roadmap of business systems.
• Evaluate, implement, and integrate CRM, ERP, QMS, MES, CTMS, HRIS, and similar apps.
• Collaborate with stakeholders to translate needs into scalable solutions.
• Support OrcaLink (Salesforce-based COC/COI) via configuration and release planning.
• Lead IT assessments with Security for secure onboarding and connectivity.
• Identify and drive AI/automation initiatives to improve operations.
• Bridge business and development teams on AI/platform initiatives.
• Mentor a small team of business systems analysts/administrators.
• Support CSV activities for GxP-regulated systems with Quality/Validation teams.
• Ensure compliance with GxP, 21 CFR Part 11, HIPAA, ISO 27001, SOC 2, NIST; maintain docs and SOPs.

Conocimientos

Business systems

Stakeholder management

Regulatory compliance

AI applications

Automation

Team leadership

GxP

CSV

Data security

Communication

Educación

Bachelor's degree in Computer Science, Information Systems, Business, or related field

Herramientas

Salesforce

AWS

TrakSYS

NetSuite

MasterControl

Veeva

Descripción del empleo

Orca Bio is seeking a hands-on Manager/Senior Manager, Business Systems to own daily administration, implementation, and roadmap across CRM, ERP, QMS, MES, CTMS, and HRIS platforms. You will partner with stakeholders, manage contracted development teams, and ensure systems are secure, compliant, and increasingly powered by AI.

You will lead a small team of analysts/administrators, support CSV activities, and ensure GxP, 21 CFR Part 11, HIPAA, and ISO 27001 compliance.