Technology Quality Specialist I

This is a fully remote position, open to applicants in India.

📋 Description

• Serve as a Quality Representative and custodian of the Parexel Quality System, championing quality throughout the organization and with clients.

• Assist in the development, execution, and oversight of Parexel's strategic objectives.

• Create and maintain communication structures for prompt and effective resolution of quality issues.

• Perform administrative tasks, ensuring accurate and timely completion of TIME documentation.

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

• Lead initiatives to identify risks and enhance value in process architecture, including Standard Operating Procedures, policies, and supporting documentation.

• Aid in the development, implementation, and ongoing improvement of training and adoption programs focused on infrastructure, change control, and problem management processes.

• Offer guidance, consultation, and expertise to project teams throughout the clinical trial and validation lifecycles.

• Monitor compliance status and activities to ensure adherence to regulatory standards across technologies, business areas, or portfolios.

• Assist in identifying requirements for validation deliverables, including planning, resource estimates, risk and impact assessments, summary reporting, and electronic records/signature regulations.

• Help with risk mitigation, categorization, and planning strategies.

• Support third-party supplier audits by reviewing vendor validation packages and ensuring their adequacy.

• Manage technology-related Quality Issues, including issue description, classification, root cause analysis, and corrective/preventive actions.

• Assist Change Control Board members in evaluating and approving or denying change requests from a technology quality and validation standpoint.

• Aid audit and inspection hosts with planning, coordinating, and presenting standard information covering the Technology Solution Life Cycle and general IT domains.

• Help compile and finalize responses for audits.

• Provide quality and GxP regulatory guidance for technologies utilized in clinical trials or trial programs.

• Support the development of risk management processes that conform to industry best practices and standards.

• Contribute to Requests for Information and proposal activities by reviewing and updating information to ensure alignment with quality and compliance standards.

⛳️ Requirements

• Entry-level experience in Computer Technology Quality & Compliance, including Computerized System Validation (CSV/CSA) within the pharmaceutical and life sciences sectors.

• Familiarity with Clinical Drug Development processes for Phase I, II, III, and IV studies, as well as manufacturing operations in regulated GxP environments.

• Practical knowledge of FDA regulations, EU regulations, and ICH guidelines related to validation, compliance, and assurance of computerized systems in GxP-regulated settings.

• Understanding of GAMP 5 principles for the validation and assurance of computerized systems, including new AI-enabled applications.

• Basic knowledge of continuous improvement methodologies and initiatives aimed at enhancing quality-driven processes.

• Proficiency in core project management functions, including planning, coordination, tracking, and execution support.

• Excellent interpersonal, verbal, and written communication skills.

• Strong business acumen, organizational abilities, stakeholder management, and negotiation skills.

• Capability to thrive in a customer-oriented, fast-paced, and dynamic environment while managing multiple priorities and deadlines.

• Self-motivated with a proactive approach to learning and ongoing development.

• Strong sense of ownership, urgency, and dedication to resolving issues and achieving project goals.

• Cultural sensitivity and ability to collaborate effectively in global settings.

• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint), Adobe Acrobat PDF, and other common desktop productivity tools.

• Capacity to work independently with appropriate guidance while upholding compliance, quality, and operational excellence standards.

• 2–3 years of relevant experience.

• Entry-level experience in clinical trials and/or research, with a focus on GCP and technology compliance.

• Familiarity with technology related to clinical trial activities, including System Life Cycle processes and relevant GCP regulations applicable to Computer Systems.

• Basic knowledge of project management, Lean Six Sigma, auditing, and/or risk management methodologies.

• A degree in technology, biological science, pharmacy, or a related health discipline is preferred, or an equivalent qualification.

🏝️ Benefits

• Full-time employment