[Hiring] Senior Technology Auditor @Parexel

Role Description

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

• Lead, Perform and Report audits
• Independently lead, plan, schedule, perform, and report a range of GxP audits across all phases of Clinical Research.
• Perform and deliver high quality audits/audit reports within specified timelines/budgets.
• Ability to review and identify improvements that enhance the quality and clarity of audit reports.
• Travel internationally for audits as required (up to approx. 60%).
• Manage GxP audits and collect/review responses to audit findings.
• Act as point of consultancy for Operations and Quality regarding CAPAs.
• Lead and coordinate internal audit programs (global and regional).
• Report outcome and trends of audit program to the process owner, QA Senior Management.
• Act as QA Lead on audits program(s) and arrange meetings with clients.
• Support Serious Breaches investigations and help oversee project teams.
• Support the training and mentoring of new/less experienced auditors.
• Maintain QA records/systems and provide QA Senior Management with reports.
• Optimize new and existing processes to maintain and improve quality standards.
• Provide consultation and interpretation on regulatory compliance.
• Facilitate client audits/regulatory inspections as assigned.
• Build, develop, and maintain good working relationships with internal and external customer groups.

Qualifications

• Minimum of 4 years experience in quality assurance, auditing, including sound experience of applicable GxP auditing.
• At least 7 years’ experience in regulatory affairs, clinical research, monitoring, data management, safety/pharmacovigilance, pharmacy, laboratory, or other relevant area in life science.
• Excellent knowledge, understanding and experience of Good Practices (GxPs) and international, national and local regulations related to clinical trials.

Requirements

• Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification.
• Master’s degree in a science, technology or industry related discipline preferred.

Benefits

• Support client QA needs and identify areas where billable services may be offered.
• Develop and optimize new and existing processes to maintain and improve quality within the billable group.
• Excellent time management skills with the ability to prioritize workload and manage multiple tasks/projects.