Senior Technology Quality Assurance Auditor

6 days ago

Billerica MA United States Parexel International Corporation Full time

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 of traveling 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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