Technology Quality Oversight Specialist

This is a fully remote position, open to applicants in Lithuania, +3 more countries.

📋 Description

• Ensure quality oversight for the development, validation, implementation, and maintenance of technology solutions.

• Conduct independent reviews of validation packages, which include requirements, risk assessments, testing evidence, traceability, and validation reports, to guarantee compliance and readiness for inspection.

• Oversee adherence to regulatory requirements, industry standards, and established procedures.

• Act as a Quality Representative for technology quality matters, audit findings, Corrective and Preventive Actions (CAPAs), and compliance initiatives, collaborating with stakeholders to ensure timely and effective resolutions.

• Lead root cause analysis activities, develop remediation plans, and create CAPAs to address compliance and validation challenges related to technology.

• Evaluate AI-driven solutions and emerging technologies with regard to quality and compliance.

• Assist in customer audits, regulatory inspections, and internal audits by acting as a subject matter expert on technology quality and facilitating responses to inquiries about validation and compliance.

• Support quality assessments of suppliers and vendors.

• Keep documentation ready for inspection and aid in maintaining audit preparedness.

⛳️ Requirements

• 3–5 years of experience in computerized system validation, technology quality, clinical research, pharmaceutical quality, or GxP-regulated environments.

• Proven experience in supporting technology projects and validation efforts.

• Familiarity with Software Development Life Cycle (SDLC), validation lifecycle, change control, CAPA, and risk management.

• Proficient understanding of computerized system validation principles.

• Knowledge of GxP regulations including Good Clinical Practice (GCP) and electronic records/signatures.

• Awareness of risk management and quality systems.

• Strong analytical, problem-solving, and communication skills.

• Excellent ability to manage stakeholders effectively.

• Capable of prioritizing multiple tasks in a fast-paced global environment.

• Bachelor’s degree in Computer Science, Information Systems, Engineering, Life Sciences, Pharmacy, Quality Management, or a related field; or a suitable combination of education and relevant experience.

🏝️ Benefits

• Engage with cutting-edge technology solutions while enhancing your expertise.

• Work in a collaborative environment.

• Opportunity to contribute to the improvement of global health.