Senior Specialist, Quality Assurance

This is a fully remote position, open to applicants in Turkey, +4 more countries.

📋 Description

• Prepare and execute quality assurance audits.

• Create audit reports and communicate findings to QA management and relevant external stakeholders.

• Collaborate with teams to ensure that corrective and preventative actions address QA observations.

• Analyze and utilize critical-to-quality factors to identify potential risks and prepare risk-based audits.

• Utilize analytics dashboards and quality metrics to identify trends, prioritize audit focus areas, enhance risk-based decision-making, and provide quality insights.

• Influence, partner with, and collaborate with colleagues both within and outside the team.

• Perform GCP audits of investigator sites, studies, suppliers, third-party collaborations, and due diligence activities.

• Assist in identifying audit substrates for scheduling in accordance with risk assessments.

• Report quality issues, potential misconduct, and significant deviations to the QAL and TA Head.

• Provide daily support to the relevant QA functional line for quality oversight of assigned studies.

• Support, enhance, and drive Clinical Quality capacity planning and the assignment of GCP audits.

⛳️ Requirements

• Bachelor's or equivalent degree and/or experience in a relevant field.

• Mastery of the primary activities and key skills required for the position.

• Experience or proficiency in compliance audits.

• Skills in data analysis.

• Detail-oriented mindset.

• Capability in deviation management.

• Ability to lead by influence.

• Skills in process improvement.

• Knowledge of quality assurance systems.

• Understanding of quality risk management.

• Proficiency in technical writing.

• Willingness to travel 50%–70% of the time.

• Ability to support, enhance, and drive Clinical Quality capacity planning and the assignment of GCP audits.

🏝️ Benefits

• Flexible remote work options.

• Regular employee status.

• Opportunities for travel (50%–70%).