Computer Systems Validation Manager - Remote/Virtual

Job description

·        
Ensures compliance with applicable quality
systems (QMS/SDLC/CSV). Manages periodic
review and maintenance of any bridges between Customer and quality systems.
·        
Reviews documents for compliance with quality
and regulatory requirements.
·        
Documents processes related to quality
management and computer system validation.
·        
Tracks training compliance for named 
resources supporting FDA-regulated accounts. 
·        
Works with Xerox functional managers to ensure
compliance with training requirements and SLAs.
·        
Participates in Compliance governance activities
(strategic and tactical initiatives, process harmonization, issues, risk
management, etc.)
·        
Supports Account Team and Management in
assessing quality / regulatory requirements and risks related to contract
activities.
·        
Provides training and guidance to  Service Delivery
teams regarding support of regulated Customers.
·        
Provides guidance to Atos staff for planning
and executing Equipment Qualification.
·        
Assesses risk related to installation of new
infrastructure or changes to existing infrastructure.
·        
Works with Atos staff to develop specific
documentation required to qualify infrastructure and support its ongoing
operation and eventual decommissioning. Reviews documents and reports for compliance with quality and regulatory
requirements.
·        
Manages deviations that occur during
qualification.
·        
Provides guidance to Atos staff for the
validation of Atos application systems used to support FDA-regulated
Customers.
·        
Performs system risk assessments related to the
intended use of new systems and their interaction with existing computer
systems.
·        
Works with staff to develop specific
documentation required to support planning, specification, design,
installation, testing, ongoing operation, and decommissioning of validated
systems. Reviews documents for
compliance with quality and regulatory requirements.
·        
Reviews executed test protocols, reports and
deviations for application testing for compliance with quality and regulatory
requirements.
·        
Participates in Customer or regulatory agency
audits of sites. Coordinates responses and remediation activities.
·        
Coordinates input into Customer or
regulatory agency audits of Customer sites.
·        
Reviews developed documents for compliance
with quality and regulatory requirements.

Desired profile

EDUCATION AND TYPICAL YEARS OF EXPERIENCE
·        
Bachelor’s Degree in IT or related field
·        
6-8 years of IT experience with 3-4 years of
direct experience in FDA-regulated environment. This includes a thorough understanding of and experience with the
following:
o  
IT infrastructure technology (Wintel, UNIX,
Oracle, storage, network, backup solutions, etc.)
o  
Validation and Equipment Qualification
o  
GxP regulations (GMP, GCP, GLP) and 21 CFR Part
11
o  
GAMP5, CMMI, and Six Sigma
o  
ITIL
o  
Quality management systems meeting the
requirements of ISO 20000 or ISO 9001
o  
Audit experience (SOX, SAS70, COBIT, etc.) is
desirable
·        
The qualifying candidate must possess the
following skills:
o  
Strong communications skills (verbal and
written)
o  
Ability to build positive working relationships
within the organization
o  
Strong history of Customer service and ability
to inspire confidence in Customers
o  
Ability to successfully manage concurrent tasks
from multiple customers
o  
Ability to plan, organize, and control work
activities
o  
Is results driven
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