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Technology 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 Auditors also provide guidance on best practices and address compliance issues through discussions with sponsors, investigators, and stakeholders. As experts in the field, their decisions have a substantial impact on fostering a culture of compliance, quality, and continuous improvement in clinical research organizations. The Senior Technology 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. With an in-depth understanding and knowledge of GxP compliance, regulations, Parexel procedures, and processes, the Senior Technology Auditor will independently plan, conduct, and manage internal and external audits while mentoring less experienced auditors. They may also act as QA leads for audit programs or clients. Collaborating with QA Management, they will actively contribute to process improvement, streamline processes, identify opportunities, provide consultancy on critical regulatory compliance, and ensure global and regional audit programs are performed effectively, promoting both process improvement and regulatory compliance.
Job Responsibility:
Independently lead, plan, schedule, perform, and report a range of technology audits across all phases of Clinical Research which may include but are not limited to project related audits, system and process audits, supplier qualification and re-qualification audits in order to evaluate the quality system against the appropriate regulatory requirements, relevant procedures and applicable guidelines
Perform and deliver high quality audits / audit reports within specified timelines / budgets, independently or with limited oversight
Ability to review and, if necessary, identify improvements that enhance the quality and clarity of audit reports
Travel internationally for audits, as required
Collect and review responses to audit findings and follow-up / escalate inadequate or delayed responses as necessary to ensure timelines are met and responses of satisfactory quality are obtained and formally recorded
Act as point of consultancy for Operations and Quality with regards to the implementation of adequate CAPAs with effective and timely escalation of relevant Quality Events where required
Coordinate internal global process / system audits across regions and develop all necessary tools such as report templates, checklists and standard emails
Ensure required audits are performed and reported in accordance with Parexel QA requirements, and on time
Review audit reports, responses and other program deliverable to ensure consistent high quality
Maintain required QA tools and ensure Parexel and QA systems are regularly updated with accurate information for audits and other activities
Support the training and mentoring of new / less experienced auditors by performing co-audits, delivering training, and sharing knowledge and experience.
Requirements:
At least 5 years’ experience in regulatory affairs, clinical research, monitoring, data management, safety / pharmacovigilance, pharmacy, laboratory, or other relevant area in life science such as technology, third party supplier management
Minimum of 2 years' experience in quality assurance, auditing, including sound experience of applicable GxP technology auditing
Excellent knowledge, understanding and experience of Good Practices (GxPs) and international, national and local regulations and laws related to clinical trials and other clinical research
Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience
Master’s degree in a science, technology or industry related discipline, preferred.