Senior QA Auditor

Parexel International Corporation

Shanghai, Shanghai Municipality, China

PAREXEL International

Job Description Template

TP-HR-WW-001-09 JD Version Date: 24 Oct 18

Effective date: 25 Jul 18

Related to: SOP-HR-WW-001 Page 1 of 3


Job Title Compliance Manager

Department Quality Assurance


Location Worldwide

Reports To (Associate) Director/ (Senior) Manager, QA

Directly Supervises N/A

Provides Work Direction


QA Team

Works Closely with PAREXEL Quality, all PAREXEL SBUs and Clients as appropriate

External Relationships Regulatory Authorities and Clients as appropriate

Billable Job x Yes  No Per assignment, as applicable

Select One x Individual Contributor  People Manager

Job Purpose:

Have a high level of knowledge and experience of appropriate GxP compliance and other applicable

regulations and laws, PAREXEL procedures and appropriate PAREXEL processes to conduct audits and

provide expert advice to internal and external clients. To effectively lead, matrix manages, develop, and

implement assigned projects. To exhibit a high degree of flexibility and initiative, demonstrate the ability

to follow up on multiple tasks and projects, and possess the ability to handle confidential information


Key Accountabilities:

The Compliance Manager will have a primary role in the management/coordination/oversight of QA

compliance GCP activities in a specific geographical and/or functional/specialist area, as assigned by QA

Senior Management. Alternatively, or in addition, the Compliance Manager can act as the QA Lead / QA

Lead back-up for a Strategic Partnership or a client account for which QA representation is needed. Other

duties may include the Auditor Coordinator role, as assigned.

• Work independently and as part of the QA team

• Act as expert GxP consultant in relevant area to groups within the PAREXEL organization and

PAREXEL sponsors

• Train new and existing QA personnel

• Train and educate operational staff by the development and presentation of training courses

• In liaison with the QA management, promote compliance within the company and represent QA,

as required

• Build, develop, and maintain good working relationships with internal and external customer


• For area of specialization, work with internal customers and develop and execute strategic audit

plans for the area

PAREXEL International

Job Description Template

TP-HR-WW-001-09 JD Version Date: 24 Oct 18

Effective date: 25 Jul 18

Related to: SOP-HR-WW-001 Page 2 of 3

• In liaison with the QA management matrix, manage projects, including teams of multifunctional

personnel, as needed

• Deputize for QA management within area of specialization

• Review the work of the matrix team to ensure consistency and quality within the group

• Act as a contact with members of Regulatory Authorities and / or sponsors; help lead in their

audits / inspections in agreement with QA management

• Contribute to the information provided to QA management to summarize quality issues arising

Qualifications• Master’s degree in a science, technology or industry related discipline, preferred

2020-06-30 01:00:32

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