IT Quality & Compliance Consultant

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San Diego, CA




9 months

Start Date

May 1, 2023

Reference #


Job Description

We’re seeking a Sr IT Quality & Compliance Analyst for a consulting position with our award-winning, San Diego headquartered global biotech client.

Sr IT Quality & Compliance Analyst should have experience with:
o Experience with regulatory compliance processes and frameworks for managing IT systems compliance.
o Experience working in pharmaceutical, life science or bio tech domain
o Knowledge of common IT infrastructure systems and applications, e.g., operating systems, virtualization, directory services, storage, network, cloud, DBMS, ERP, CRM, LMS, etc.

* Start Date: May 1 2023
* Duration:9-month contract with the potential to extend
* Location: San Diego, CA or REMOTE from the United States
* Work hours: Supporting the Pacific time zone
* Direct W2 contract only, no third parties
* Compensation: Approximately $50 – $62/hr W2 – The offered rate to a successful candidate will be dependent on several factors that may include (but are not limited to) the type and length of experience within the industry, location, education, etc.

Role Overview
• Responsible for guiding the Global Information Services (GIS) Organization on requirements analysis, risk assessment, and validation/verification activities.
• Coordinates the Change Management process within the GIS organization.
• Reviews system changes to provide compliance assessments and closure summaries that are audit ready.
• Advises project teams and internal GIS customers on validation scope, risk, and validation approach.
• Assist and lead process improvement projects related to regulatory compliance within the GIS Organization.
• Operate independently to manage end to end compliance activities within projects.
• Develops and maintains software and hardware testing protocols (knowledge of different types of testing such as integration, unit, regression testing).
• Responsible for Validation Documentation
• Participates in project and system requirements gathering/authoring; coordinates activities with business users and analysts.
• Investigates root-cause of defects, failures and authors and/or investigates Non-conformances and CAPAs.

• Bachelor’s degree
• Experience with Computer Systems Validation (CSV) for common IT infrastructure and applications, e.g., virtualization, directory services, storage, DBMS.
• Experience with enterprise applications such as ERP, CRM, LMS, LIMS, MES, etc. • Experience with regulations and frameworks – e.g., 21 CFR Part 820/11, ISO 13485, SOX, HIPAA and GAMP.
• Experience with Test Management tools such as HP Quality Center, Valgenesis and TFS.
• Ability to articulate risk-based validation strategy and provide tailored validation approach to meet the business needs.
• Experience and leadership in fast-paced project implementations.
• Experience with software development lifecycle activities, methodologies, testing and validation.

Soft skills:
• Strong oral and written skills to persuade, direct and advise stakeholders on regulatory compliance processes.
• Strong organizational skills to maintain and manage multiple validation projects
• Excellent customer service and communication skills.
• Good collaboration skills, highly detail-oriented, with the ability to perform responsibilities with minimal supervision
• Ability to work well will with multiple teams

Please apply today!

For more information, please email: #LI-LS1 #LI-DNI #LI-Remote

IT Quality & Compliance Consultant

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