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.
As a Senior Technology Quality Assurance (TQA) Auditor you will have the experience and knowledge to provide guidance and facilitate the effective preparation, conduct 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 provide significant influence and impact on the quality and compliance of computerized systems utilized within clinical trials. They autonomously assess technology, data integrity controls, 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, third-party suppliers, and internal stakeholders. Travel is infrequent, maximum 20% of your time.
Accountabilities:
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Lead Third-Part Supplier and Internal Technology Audits
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Prepare for, Conduct, Report on, and Follow-up on findings from audits
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Support Serious Breach investigations
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Support Auditor Training and Mentoring
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Maintain QA Records / Systems
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Support Sponsor Audits and Regulatory Inspections
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Maintain sound knowledge of Parexel policies, procedures, and guidelines and promote a culture of quality and compliance within Parexel
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Build, develop, and maintain working relationships with internal and external customer groups
Skills:
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Excellent interpersonal, verbal and written communication skills
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Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
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Experience with Microsoft based applications and ability to learn internal and supplier computer systems
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Willingness to work effectively with minimal supervision in a matrix environment and to value the importance of teamwork
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Ability to develop relationships with culturally diverse stakeholders, including Parexel team members and sponsor representatives
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Ability to work professionally with highly confidential information
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Flexibility and ability to adjust to changing priorities and unforeseen events
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Excellent time management skills and the ability to follow-up on multiple tasks and projects
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Ability to diplomatically address sensitive issues confidentially and professionally
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Ability to work consistently in a fast-paced environment
Knowledge and Experience:
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Strong knowledge of GxP regulations and guidance, industry standards, and best practices for data integrity and technology used to support clinical trials.
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Familiar in processes specific to the development, validation, maintenance, and use of technology within clinical trials, including Software Development Lifecycle (SDLC), Test Management, Change Control, etc.
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Five to nine years of in Technology Quality Assurance Auditing, and/or relevant Technology Quality Management experience
Education:
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Educated to degree level (information technology, information systems, biological science, or other related discipline preferred) or equivalent qualification or clinical research experience
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ASQ CQA and or CISA preferred
