R & D IT Compliance Lead

Zifo is hiring for a compliance Lead to work with one of our Life Science clients in Emeryville, CA

This is a contract role - open to independent contractors.

This role will require 3 days per week on-site at our client in Emeryville, CA

This role is not eligible for visa sponsorship - candidate must be a US citizen or hold a Green Card

This role will not qualify for any relocation assistance

Requirements

Qualifications:

• Bachelors or Master's degree in biology, biomedical engineering, chemistry, or a related field
• More than 10 years of industry experience working within the Lifesciences industry working closely with System Validation / Quality Assurance,GxP regulations & IT compliance
• Working experience on SaaS Validation (e.g systems ELN/LIMS, Clinical trial and data management systems, Clinical submission systems)

• At least 8 years of experience working with IT Change Management, Software Development Life cycle (SDLC) Service Continuity Data Protection/Backup
• Skilled at System Access & Inventory Management, IT Incident, Non-Conformance, CAPA Management, IT Document Control, Training & Curriculum Management
• Functioned as the primary IT contact for all GxP compliance audits and inspections.
• Experienced in development of IT compliance training to ensure staff understand & adhere to IT policies, procedures, controls & tools to ensure a compliant & consistent IT control environment.

Responsibilities:

• Ensures IT operates in compliance to GxP regulations & ensures compliance objectives are demonstrably met with auditable evidence on an ongoing basis.
• Builds effective partnerships with business process owners, IT system owners, system administrators, Quality staff, internal/external auditors, inspectors & other cross-functional stakeholders to develop, implement & maintain the IT compliance program.
• Manages IT policy, process & control effectiveness & to ensure compliance objectives are demonstrably met for in scope IT systems, data & processes.
• Develops, manages & maintains compliance strategy, governance, policies, processes, controls, improvements, risk assessments, compliance checks & team domain knowledge to ensure the following key activities are effectively & efficiently executed for IT systems:
• System Validation/Assurance, Periodic Review
• IT Change Management & SDLC
• Service Continuity & Data Protection/Backup
• System Access & Inventory Management
• IT Incident, Non-Conformance, CAPA Management
• IT Document Control, Training & Curriculum Management
• Manages IT compliance-related staff, service providers, budgets, audits, inspections & projects.
• Conducts risk assessments of key systems, accounts, & other in scope areas & activities to inform & ensure compliance.
• Directly manages and acts as the primary IT contact for all GxP compliance audits and inspections.
• Provides expert consulting across stakeholders of the IT regulatory landscape & upcoming changes, of compliance requirements & best practices & of continuous improvement.
• Leads the development of IT compliance training to ensure staff understand & adhere to IT policies, procedures, controls & tools to ensure a compliant & consistent IT control environment.
• Develops, socializes & reinforces responsibility matrices to ensure compliance responsibilities are clearly understood.

Qualification

Bachelor's Degree