Systems Validation Specialist II

This is a fully remote position, open to applicants in Argentina, +1 more country.

📋 Description

• Serve as a custodian and leader of the Parexel Quality System while acting as an ambassador for quality within the organization and with clients.

• Assist in the development, implementation, and management of Parexel's strategic objectives.

• Create and uphold a communication framework that alleviates constraints and fosters timely and effective actions regarding quality issues.

• Work collaboratively with functional leads to design, re-engineer, implement, and adopt the quality framework for the validation and release of interfaces and solutions.

• Spearhead efforts to identify low- and medium-risk or value improvements in process architecture, including Standard Operating Procedures, manuals, and related quality system documentation.

• Aid in the development, implementation, continuous improvement, training, and adoption of processes related to infrastructure, change control, and problem management.

• Offer guidance, consultation, and quality expertise to project teams involved in clinical trials and validation activities throughout the applicable lifecycle.

• Support the oversight and monitoring of compliance status and activities for projects, business areas, or portfolios, which includes validation planning, resource estimates, risk and impact assessments, summary reporting, and adherence to Electronic Records/Electronic Signature regulations.

• Assist in risk mitigation by identifying, categorizing, and defining risks along with their associated mitigation plans.

• Support internal customers in managing technology-related Quality Issues, which encompasses issue descriptions, classification, oversight of root cause analysis, and consultation on corrective and preventive actions.

⛳️ Requirements

• A minimum of 3 years of experience in clinical research and/or clinical trials, focusing on GCP and technology compliance.

• Familiarity with technology as it pertains to clinical trial activities, including the System Life Cycle process and relevant GCP regulations regarding computer systems.

• Basic understanding of continuous improvement methodologies.

• Proficient in core project management activities.

• Degree-level education in technology, biological sciences, pharmacy, or another health-related field is preferred; an equivalent qualification is acceptable.

• Strong ability to prioritize workload and manage a variety of tasks with enthusiasm.

• Mid-level experience in computer technology quality and compliance within the pharmaceutical industry across various disciplines in Clinical Drug Development and/or Manufacturing.

• Exceptional interpersonal, verbal, and written communication abilities.

• Business acumen and negotiation skills.

• Strong organizational capabilities.

• Capacity to thrive in a customer-focused, fast-paced, rapidly changing, and global environment.

• Intermediate proficiency in desktop software, including MS Office, Excel, and Adobe PDF.

• Experience in Clinical Drug Development Phases I, II, III, and/or IV and/or Manufacturing is preferred.

• Knowledge of project management, Lean Six Sigma, auditing, and/or risk management methodologies is preferred.

• Cultural awareness and the ability to think and work globally are preferred.

🏝️ Benefits

• Flexible work arrangements, including remote work options.

• Opportunities for professional development and to enhance expertise in computerized system validation, technology compliance, quality systems, project management, auditing, and risk management.

• Opportunities to contribute to clinical research across multiple phases of drug development.