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PAREXEL International LLC Senior Technology Quality Assurance Auditor in United States
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Senior Technology Quality Assurance Auditor United States of America, Remote Additional Locations: Remote - United States of America Job IDR0000025519 CategoryQuality Management
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About this Role
Home Based, US
As a Senior Technology Quality Auditor (TQA) you will have the experience and knowledge to provide guidance and facilitate the effective preparation, management and follow up of internal and supplier technology audits. You will 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 diplomatically. The TQA Senior Auditor will play a crucial role in conducting audits that impact business operations, processes, and systems, contributing to meeting client needs and maintaining high compliance standards.
Technology Quality auditors possess significant authority and decision-making power within clinical trials. They autonomously assess technology, data integrity practices, and regulatory compliance, recommending necessary changes to ensure adherence to standards when deviations or non-compliance are identified. Technology Quality auditors also provide guidance on best practices and address compliance issues through discussions with sponsors, investigators, and stakeholders. The requirement is to be capable oftraveling up to 60%of the time.
Accountabilities:
Lead, perform and report audits
Manage Technology audits
Lead and coordinate internal audit programs (global and regional)
Support Serious Breaches
Support Auditor Training and Mentoring
Maintain QA Records / Systems
Support Sponsor Audits and Regulatory Inspections
Maintain sound knowledge of Parexel policies, procedures, and guidelines and promote compliance within Parexel
Build, develop, and maintain working relationships with internal and external customer groups
Skills:
Excellent interpersonal, verbal and written communication skills
Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
Experience with Microsoft based applications and ability to learn internal and supplier computer systems
Willingness to work effectively with multiple supervisors in a matrix environment and to value the importance of teamwork
Ability to develop relationships with culturally diverse stakeholders, including Parexel team members and sponsor representatives
Ability to work professionally with highly confidential information
Flexibility and ability to adjust to changing priorities and unforeseen events
Excellent time management skills and the ability to follow-up on multiple tasks and projects
Ability to diplomatically address sensitive issues confidentially and professionally
Ability to work consistently in a fast-paced environment
Knowledge and Experience:
Strong knowledge of GxP, industry standards, applicable international technology compliance regulations
Must be detail oriented and able to maintain a ‘big picture’ overview during a sponsor audit or inspection
Ability to follow up on multiple tasks and projects, and to handle confidential information diplomatically
Familiar in technology as it relates to clinical trial activities, including System Life Cycle process and applicable GCP regulations pertaining to Computer Systems
Education:
Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience
Five to nine years of experience in Quality Assurance, auditing, relevant Quality Management and clinical trial support
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EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
