Systems Validation Specialist II

About the role

Parexel, a global clinical development partner, is looking for a Systems Validation Specialist to join its team in Argentina or Mexico in a fully remote capacity. The specialist supports the definition, adoption and oversight of compliant processes and standards that underpin technology solution development, validation and delivery, working with business and functional stakeholders on quality frameworks, project quality oversight, continuous improvement, audits and inspections, and GxP regulatory guidance.

Key responsibilities

• Custodian and leader of the Parexel Quality System and quality ambassador across the business and with customers
• Support the development, implementation and management of Parexel's strategic objectives
• Work with management and peers to set up a communication framework for quality matters
• Collaborate with functional leads to design, re-engineer and adopt the quality framework for validation and release of interfaces and solutions
• Lead activities to identify low- and medium-risk process improvements, including SOPs, manuals and quality system documentation
• Support infrastructure, change control and problem management processes, and train project teams on clinical trial and validation activities
• Oversee compliance status, validation planning, risk and impact assessments, summary reporting and Electronic Records/Electronic Signature regulations where applicable
• Assist with risk mitigation and support Quality Issue management, including root cause analysis and corrective and preventive actions

Required profile

• 3+ years of experience in clinical research and/or clinical trials with emphasis on GCP and technology compliance
• Familiarity with technology in clinical trials, including the System Life Cycle process and applicable GCP regulations for computer systems
• Basic knowledge of continuous improvement methodologies and core project management activities
• Degree in technology, biological science, pharmacy or another health-related discipline preferred; equivalent qualification accepted
• Ability to prioritize and manage multiple tasks in a fast-paced, global environment

Required skills

• Computerized system validation and quality and compliance
• Intermediate desktop software skills, including MS Office, Excel and Adobe PDF
• Preferred: experience across Clinical Drug Development phases I-IV and/or manufacturing, and knowledge of Lean Six Sigma, auditing and risk management