Overview
On Site
USD 40.00 - 45.00 per hour
Full Time
Skills
GxP
Data Security
System Documentation
Regulatory Compliance
Testing
Acceptance Testing
IQ
OQ
PQ
Technical Support
Identity Management
Collaboration
Verification And Validation
Management
System Security
Pharmaceutical Industry
Quality Control
Computer Science
Information Technology
Pharmaceutics
Biotechnology
Law
Job Details
A leading organization in the pharmaceutical and biotechnology sector is looking for an IT Manager fo an on-site position in Clayton, NC. This role involves overseeing IT systems throughout their lifecycle, ensuring regulatory compliance, driving project goals, and collaborating with stakeholders for seamless and secure operations.
Key Responsibilities of the IT Manager - Pharmaceutical/Biotechnology Industry:
Application Timeline: Opens May 27, with a minimum 30-day application acceptance period.
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Key Responsibilities of the IT Manager - Pharmaceutical/Biotechnology Industry:
- Manage end-to-end lifecycle of IT systems, ensuring adherence to corporate policies and regulatory requirements (21 CFR Part 11, GxP, and personal data protection regulations).
- Maintain detailed system documentation, including validation reports, configuration baselines, and operational manuals to support compliance.
- Conduct system assessments, testing (FAT, SAT, UAT, IQ, OQ, PQ, GEP), and risk evaluations to uphold security and functionality.
- Act as the escalation point for IT support, resolving issues related to access management, troubleshooting, and coordination between internal and external teams.
- Drive project deliverables, managing timelines while working collaboratively with cross-functional stakeholders.
- Support software validation and management for standalone applications, ensuring best practices for system security and maintenance.
- 2-5 years of experience within the pharmaceutical industry.
- Approximately 3 years of IT validation experience within regulated environments.
- Strong IT background, preferably with 2+ years of IT or QC administrative experience.
- Demonstrated ability to work with quality control (QC) software and quickly adapt to evolving technologies.
- Bachelor's degree in Computer Science, Information Technology, or a related field.
- Hourly Rate: $40-$45 per hour (USD).
- Benefits Package: Medical, Dental, Vision, 401K, and sick leave (where applicable by law).
Application Timeline: Opens May 27, with a minimum 30-day application acceptance period.
#LI-KI1 #LI-ONSITE
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