Offer summary
Qualifications:
Degree in relevant field, 5-9 years QA experience.Key responsabilities:
- Lead, perform and report audits
- Manage internal audit programs
- Support sponsor audits and inspections
When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
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.
Accountabilities:
Skills:
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:
Five to nine years of experience in Quality Assurance, auditing, relevant Quality Management and clinical trial support
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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