System Technology Compliance Senior Specialist

Job Location(s) IN-Bangalore
Job Number
Job Category
Client Services
Position Type

Job Overview

I. Job Summary:
A. Responsibilities/Duties
Indicate positions accountability
_____ GLC/General Manager
_____ Department Head/Function Lead
_____ Manager of Managers
_____ Manager
___X__ Individual Contributor
FOR GLOBAL REWARDS USE ONLY: Template Revised – May 2018 Page 2 of 4
B. People Responsibilities:
Indicate the number of:
__0___ Direct Reports
__0___ Indirect Reports
C. Essential Job Duties:
 Follow applicable departmental Standard Operating Procedures and Work Instructions.
 Complete required trainings according to required timelines.
 Audits System Life Cycle (SLC) activities and documentation
 Plan, conduct, and lead global internal facility, system, and process audits
 Plan, conduct, and lead external audits of vendors and suppliers
 Participates in client and regulatory visits as the subject matter expert in the field of computerized systems and technology compliance
 Author and review controlled documents including but not limited to SOPs and policies
 Advises internal business, IT, and QA partners on systems and technology compliance
 Leads and actively contributes to process and continuous improvement projects
 Ensure Regulatory Compliance and Quality Assurance (RC&QA) responsibilities, as indicated in applicable controlled documents, are followed.
 Other duties as assigned by management.
D. Scope
 Describe scope of position (global vs. regional vs. domestic)
____ Domestic – Location(s) within a single country or neighboring countries with similar
_____ Regional – Continental Region (e.g. Europe, Eastern Europe, Asia, North America,
Latin America, Middle East)
__X__ Global – All regions of the world
 Single vs. Multiple Business Units or cost centers
__ __ Single
_____ Multiple
__X_ Covance wide
 Indicate the scope of financial responsibilities (Revenue and/or Budget responsibilities (if applicable)
_____N/A___ Annual/Revenue
_____N/A___ Annual Operating Budget
E. Principal Contacts and Scope of Communications
 Primary internal stakeholders include RC&QA, Operational Teams
Type of Communication
Strategic – Manage communications of great importance having long term implications
_____ Internal
_____ External
_____ Daily
_____ Weekly
_____ Monthly
_____ Annually
FOR GLOBAL REWARDS USE ONLY: Template Revised – May 2018 Page 3 of 4
Negotiate – Come to agreement through discussion and compromise – short to medium impact
__X___ Internal
_____ External
__X__ Daily
_____ Weekly
_____ Monthly
_____ Annually
Influence – Effect change where persuasion is required – short term impact
_____ Internal
_____ External
_____ Daily
____ Weekly
_____ Monthly
_____ Annually
Convey – Communicate information: could be a statement, suggestion, gesture or appearance
_____ Internal
_____ External
____ Daily
____ Weekly
_____ Monthly
_____ Annually
F. Travel Requirements: ____X___ Yes _______No
______ Local
______ Domestic
___X__ Regional
______ Global
<5% of time
G. Language Skills Required:
 Speaking: __X___ Yes __ List Specific Languages (English preferred or required)
 Writing/Reading: __X___ Yes _ List Specific Languages (English preferred or required)


III. Education/Qualifications/Certifications and Licenses
 A minimum of a Bachelor’s Degree in Life Sciences preferred (or equivalent Life Science experience)
 Experience may be substituted for education.


II. Experience:
Minimum Required:
 3 years in regulatory environment (system compliance experience)
 Must have a sound understanding of standard computer system development life cycles to provide necessary guidance to both information technology and operational personnel.
 Thorough knowledge and understanding of GxP and computerized systems regulations and regulatory guidelines.
 Experience applying regulations in at least one GxP discipline and computerized systems standards to the conduct of drug development.
 Ability to confidently interact with clients and regulatory personnel
 Ability to conduct effective training
 Ability to effectively negotiate ideas and suggestions.
 Strong analytical, organizational, and interpersonal skills


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