Job Overview:
Essential Job Duties:
Conduct work as identified on the audit activity table (listing on table is not all inclusive but a
representative sample)
Development and delivery of training (to operational groups)
Delivery of training in performance of audits (basic, intermediate audit activities)
Provide advice and guidance on aspects of quality and compliance
Provide consultation to the operational team on quality issues
Cross-site QAand operational relationship, provide recommendations for improving
compliance and/or efficiency
Work with operational management to support Quality topics and/or working on projects with
QA team on other sites [showing development of collaboration skills]
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Manage local Quality initiatives aimed at improving compliance and/or efficiency of the local
QA organization
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
cultures
X Regional - Continental Region (e.g. Europe, Eastern Europe, Asia, North America,
Latin America, Middle East)
Global - All regions of the world
Single vs. Multiple Business Units or cost centers
Single
X Multiple
Co vance 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
F. Travel Requirements: X Yes No
Local
Domestic
X Regional
Global
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)
IV. Competencies:
Information purposes only:
The Covance Competencies define the behaviors necessary for the organization to achieve
business outcomes. Please refer to the Covance Competencies formore information about
company-wide expectations for all employees.
V. Working Conditions:
Tasks involve sitting in front of a terminal for many hours during the working day.
VI. Special Factors:
Some overtime and weekend work may be required
Education/Qualifications:
Recommended:
A minimum of a Bachelor's Degree in Life Sciences preferred (or equivalent Life Science
experience)
Experience may be substituted for education.
Experience:
Mnimum Required:
4 years in regulatory environment (experience in GXP roles)
Experienced GxP auditor
Able to influence QA strategy
Ability to communicate to groups
Knowledge of multiple operational areas
Knowledge of industry quality systems/standards and ability to apply appropriate regulatory
knowledge to multiple scenarios