Systems Validation Specialist II

Summary

Parexel is a global clinical development partner delivering clinical and consulting solutions for the life sciences industry. The Systems Validation Specialist II supports compliant processes and standards for technology solution development, validation, and delivery, while providing quality oversight, risk management, process improvement, and regulatory guidance for clinical research activities.

Responsibilities

• Act as a custodian and leader of the Parexel Quality System and serve as an ambassador for quality across the business and with customers
• Support the development, implementation, and management of Parexel strategic objectives
• Work with management and peers across the business to establish and maintain a communication framework that removes constraints and supports timely, effective action on quality matters
• Collaborate with functional leads to design, re-engineer, implement, and adopt the quality framework for the validation and release of interfaces and solutions
• Lead activities with business and team leads to identify low- and medium-risk or value improvements for process architecture, subject to quality oversight, including Standard Operating Procedures, manuals, and related quality system documentation
• Support the development, implementation, continuous improvement, training, and adoption of infrastructure, change control, and problem management processes
• Provide guidance, consultation, and quality expertise to project teams supporting clinical trial and validation activities across the applicable lifecycle
• Support oversight and monitoring of compliance status and activities for a project, business area, or portfolio, including requirements for validation planning, resource estimates, risk and impact assessments, summary reporting, and Electronic Records/Electronic Signature regulations where applicable
• Assist with risk mitigation by identifying, categorizing, and defining risks and associated mitigation plans
• Support internal customers with technology-related Quality Issue management, including issue descriptions, classification, root cause analysis oversight, and consultation on corrective and preventive actions

Skills

• Strengths in quality and compliance, computerized system validation, and continuous process improvement
• Mid-level experience in computer technology quality and compliance and the pharmaceutical industry across multiple disciplines within Clinical Drug Development and/or Manufacturing
• Excellent interpersonal, verbal, and written communication skills, business understanding, negotiation skills, and strong organizational skills
• The ability to work in a customer-focused, fast-paced, rapidly changing, and global environment while prioritizing multiple and varied tasks
• Intermediate desktop software skills, including MS Office, Excel, and Adobe PDF
• 3+ years of experience in clinical research and/or clinical trials with emphasis on GCP and technology compliance
• Familiarity with technology as it relates to clinical trial activities, including the System Life Cycle process and applicable GCP regulations pertaining to computer systems
• Basic knowledge of continuous improvement methodologies and competency across core project management activities
• Degree-level education in technology, biological science, pharmacy, or another health-related discipline preferred; an equivalent qualification
• High ability to prioritize workload and manage multiple and varied tasks with enthusiasm
• Degree in technology, biological science, pharmacy, or another health-related discipline
• Experience across Clinical Drug Development Phases I, II, III, and/or IV and/or Manufacturing
• Knowledge of project management, Lean Six Sigma, auditing, and/or risk management methodologies
• Cultural awareness and the ability to think and work globally

Qualifications

Must Haves

• Strengths in quality and compliance, computerized system validation, and continuous process improvement
• Mid-level experience in computer technology quality and compliance and the pharmaceutical industry across multiple disciplines within Clinical Drug Development and/or Manufacturing
• Excellent interpersonal, verbal, and written communication skills, business understanding, negotiation skills, and strong organizational skills
• The ability to work in a customer-focused, fast-paced, rapidly changing, and global environment while prioritizing multiple and varied tasks
• Intermediate desktop software skills, including MS Office, Excel, and Adobe PDF
• 3+ years of experience in clinical research and/or clinical trials with emphasis on GCP and technology compliance
• Familiarity with technology as it relates to clinical trial activities, including the System Life Cycle process and applicable GCP regulations pertaining to computer systems
• Basic knowledge of continuous improvement methodologies and competency across core project management activities
• Degree-level education in technology, biological science, pharmacy, or another health-related discipline preferred; an equivalent qualification
• High ability to prioritize workload and manage multiple and varied tasks with enthusiasm

Nice to Haves

• Degree in technology, biological science, pharmacy, or another health-related discipline
• Experience across Clinical Drug Development Phases I, II, III, and/or IV and/or Manufacturing
• Knowledge of project management, Lean Six Sigma, auditing, and/or risk management methodologies
• Cultural awareness and the ability to think and work globally

Benefits

• Remote work capacity in Argentina or Mexico
• Opportunities to deepen expertise in computerized system validation, technology compliance, quality systems, project management, auditing, and risk management
• Flexibility and growth opportunities
• Creating space for people to do their best work