Covance

Head of China, Clinical Quality Assurance

Job Location(s) CN-Shanghai | CN-Beijing | CN-Guangzhou
Job Number
2021-78493
Job Category
Quality Assurance
Position Type
Full-Time
Telecommute
No

Job Overview

Leads GCP QA functions covering multiple sites in China. In this capacity oversees all
aspects of functional operations and is accountable for maintaining client and regulatory satisfaction with all aspects of GCP compliance in their jurisdiction.
 
 Plans and executes the necessary QA inspection programs to maintain GCP compliance
 Develops procedures as necessary to cover GCP needs
 Ensures recruitment and training of a competent and sufficient GCP QA workforce to meet business needs 
 Accountable for budgetary oversight of the China GCP QA team
 Leads communications with external Regulatory and Client compliance counterparts.
 Through direct line managers ensure consistent functional implementation, use and review of SOPs
 Effectively communicate functional strategies to internal stakeholders
 Publish executive summaries of functional and internal stakeholdermetrics/dashboards including risk mitigation, when needed
 Communicate escalation issues to management in a timely manner implementing appropriate functional solutions and providing regular updates
 Negotiate and effectively manage constructive crucial conversations with external stakeholders
 Ensure stakeholder buy-in, resources available and multidisciplinary team in place to drive strategic functional process improvement initiatives
 Act as the RC&QA solutions partner for operations to drive a strong culture of quality and compliance
 Interpret applicable quality regulations/standards and ensure appropriate policies and procedures are revised/created
 Mentor RC&QA and operational resources, to drive a quality culture
 Ensure Regulatory Compliance and Quality Assurance (RC&QA) management
responsibilities, as indicated in applicable controlled documents, are followed
 Manage the functional budget, for the multiple sites or geographic locations of responsibility
 Act as the RC&QA Leadership Team's delegate
 Represent Covance in external associations/forums/organisations, as an industry SME
 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)
 Postgraduate degree (MSC or equivalent) in science or management related discipline,preferable
 Experience may be substituted for education.

Experience

Minimum Required:
 14 years in regulatory environment (experience in GCP roles)
 Experience & regulatory expertise of industry quality systems/standards
 Ability to resource and lead a multidisciplinary team to drive strategic functional process improvement initiatives
 Ability to communicate and negotiate with external parties effectively
 Ability to distill critical information
 Ability to effectively lead teams through the management of people leaders at multiple sites orgeographic locations
 Chinese speaking is a must, and fluent speaking in English 

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