Senior Technology Quality Auditor

3 days ago

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Parexel

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Regulatory and product development consulting • early phase clinical research • phase II-III clinical research • late phase clinical research • eClinical solutions

10,000+

💰 Venture Round on 1990-01

Description

• 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

Requirements

• 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 • 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