Covance

QA Manager, Clinical Central Lab -APAC

Job Location(s) CN-Shanghai
Job Number
2021-64964
Job Category
Quality Assurance
Position Type
Full-Time
Telecommute
No

Job Overview

Essential Job Duties:
 Influence functional and operational internal stakeholders to improve quality and increase efficiencies within audits, inspections and operations
 Ensure the consistent implementation, use and review of SOPs
 Escalate issues to management in a timely manner implementing appropriate solutions, including preventative actions
 Negotiate with functional and operational internal stakeholders to improve quality and inc rease efficiencies
 Analyse and interpret data in order to lead functional process improvement initiatives to drive efficiencies and effectiveness of Regulatory Compliance & Quality Assurance (RC&QA) processes
 Lead and effectively manage constructive crucial interactions with clients or regulatory agencies
 Lead functional process improvement initiatives to drive efficiencies and effectiveness of Regulatory Compliance & Quality Assurance (RC&QA) processes
 Interpret applicable quality regulations/standards and create appropriate policies and procedures
 Ensure Regulatory Compliance and Quality Assurance (RC&QA) management responsibilities, as indicated in applicable controlled documents, are followed
 Perform other duties, as assigned by management

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

Minimum Required:
 8 years in regulatory environment (experience in GXP roles)
 Experience & regulatory expertise of industry quality systems/standards
 Ability to interpret applicable regulations/standards
 Experience in leading process improvement initiatives
 Ability to communicate and negotiate internal stakeholders effectively

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