Senior Auditor, Technology Quality Assurance

The Principal Technology Auditor will have quality oversight of the various systems and processes used for tracking, maintaining and improving enterprise-level technologies and operational frameworks as a member of the Quality Assurance department. A background in IT systems validation and/or IT auditing is highly preferred but Parexel is open to training for those who have a strong GCP compliance background. You will lead supplier audits of new and innovative clinical technologies solutions such as Artificial Intelligence, Machine Learning, Real World Data to enable patient solutions. Provide mentoring and training to internal stakeholders on technical auditing practices and regulatory interpretation; 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.

• Conduct all preparation meetings for supplier audits, assign tasks with other internal departments and gather necessary information on supplier confidentiality agreement documentation if applicable.

• Initiate planning process(es), e.g., project plans with deadlines and milestones, to administer an audit effectively and seamlessly

• Ensure audits are performed to a high degree of client satisfaction, procedural adherence and technical quality

• Build, develop, and maintain good working relationships with internal and external customer groups

• Determine most appropriate setting to host an audit, based upon audit requirements

• Develop and maintain an awareness of Parexel policies, procedures and guidelines

• Train to appropriate team members as needed

• Proactively re/review QA SOPs and be able to speak to their contents

• Identify process improvement opportunities

• Author/Support the development of associated documents

• Provide process expertise across Quality Assurance

• Assist QA Senior Management in the development and implementation of strategic procedures and working practices to ensure continuous quality improvement.

• Analyze audit activities and provide metrics to relevant parties (e.g., QA, Operations, Procurement).

• Manage projects as assigned, including teams of multifunctional personnel, as needed.

• For area of specialization, work with internal customers and develop and execute strategic plans for the area.

• Develop and present training courses as needed.

• Mentor new QA staff as assigned.

• Build, develop, and maintain good working relationships with internal and external customer groups.

• Work well in team a collaborative environment while working remotely.

• Perform other quality related tasks or duties as assigned.

• Travel domestically and/or internationally on assignments as required. Travel time could be up to 25%.Qualifications• Ability to develop relationships with a culturally diverse group of key stakeholders within Parexel and the client’s business

• Excellent interpersonal, verbal, and written communication skills, including experience in making presentations at conferences, meetings, and training sessions

• Experience with Microsoft based applications and ability to learn internal computer systems

• Excellent analytical skills – particularly in with Audit, Sponsor Audit and Inspection data

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

• Ability to work flexibly and adjust to changing priorities and unforeseen events

• Diplomatically address sensitive issues confidentially and professionally

• Analyze complex situations / issues and effectively communicate situations / issues, along with potential recommendations, to various functional groups

• Work professionally with highly confidential information

• Work independently and consistently in a fast-paced environment.

Minimum Requirements

• 7+ years’ of extensive experience in quality assurance, quality management, regulatory affairs, auditing, clinical research, monitoring, data management, safety/pharmacovigilance, pharmacy, laboratory or other relevant area with technology focus and experience

Education

• Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience

• Strong command of written and spoken English language, local language proficiency as required

• CISA certification or other similar technology auditing certification preferred but not required