I. Job Summary:
Indicate positions accountability
_____ GLC/General Manager
_____ Department Head/Function Lead
_____ Manager of Managers
___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.
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
__X_ Covance wide
Indicate the scope of financial responsibilities (Revenue and/or Budget responsibilities (if applicable)
_____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
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
Influence – Effect change where persuasion is required – short term impact
Convey – Communicate information: could be a statement, suggestion, gesture or appearance
F. Travel Requirements: ____X___ Yes _______No
<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.
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
Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed