Senior Technology Quality Auditor

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.

Key Accountabilities

• 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.

Skills

• Ability to rapidly learn, understand and apply applicable Parexel and client procedures

• Ability to work flexibly, and across multicultural environment

• Ability to learn and use Parexel and client computer systems

• Willingness to work effectively with multiple supervisors in a matrix environment and to value the importance of teamwork

• Excellent interpersonal, verbal, and written communication skills, including the ability to present at conferences, meetings and training sessions

• Excellent organizational, analytical, problem solving, decision making and negotiation skills

• Effective at analyzing problems considering the ‘big picture’ and recommending appropriate corrective actions

• Accurate and detail oriented, a critical thinker

• Excellent time management skills with the ability to prioritize workload and manage multiple and varied tasks / projects with enthusiasm

• Ability to diplomatically address sensitive issues confidentially and professionally

Knowledge & Experience

• 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

Education

• 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.