Senior Quality Operations Specialist - Clinical Research & Innovation

Consortium For Clinical Research And Innovation Singapore · 📍 Canggu, Bali, Indonesia · Diposting 2026-10-09
FULL_TIME⭐ TERVERIFIKASI
IDR 40000000 - 60000000
We are seeking a highly skilled and experienced Senior Quality Operations Specialist to join our team in Canggu, Bali. This role is crucial in ensuring the highest standards of quality and compliance in our clinical research operations. The ideal candidate will have a strong background in quality management and a passion for innovation in the field of clinical research.

📋 Tanggung Jawab Pekerjaan

Oversee and manage quality operations to ensure compliance with regulatory requirements and industry standards.,Develop and implement quality assurance and quality control procedures to maintain high standards of data integrity and accuracy.,Conduct audits and inspections to identify areas for improvement and ensure adherence to quality standards.,Train and mentor staff on quality management best practices and regulatory requirements.,Collaborate with cross-functional teams to resolve quality issues and implement corrective actions.,Monitor and report on quality metrics and trends to support continuous improvement initiatives.,Stay updated with the latest developments and best practices in quality management and clinical research.,Participate in project planning and execution to ensure quality standards are met throughout the research lifecycle.

🎓 Kualifikasi & Syarat

Bachelor's degree in a relevant field such as Pharmacy, Biology, Chemistry, or a related discipline.,Minimum of 5 years of experience in quality operations, quality assurance, or quality control in the clinical research industry.,Proven experience in regulatory affairs and compliance with international standards such as ICH-GCP, FDA, and EMA.,Strong knowledge of GCP (Good Clinical Practice) guidelines and other relevant regulatory requirements.,Excellent communication and interpersonal skills, with the ability to work effectively in a team environment.,Proficiency in English, both written and spoken, is essential.,Knowledge of data management systems and electronic data capture (EDC) tools is a plus.,Certification in quality management or a related field is a plus.

🛠️ Keahlian

Quality ManagementRegulatory AffairsData IntegrityProject ManagementTraining and DevelopmentProblem-SolvingContinuous ImprovementCompliance Management
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