Astrum

General

• Work autonomously within core responsibilities to maintain compliance and quality excellence.
• Develop, update, and review Q&C quality standards, processes, and procedures to ensure compliance with regulatory requirements.
• Promote adherence to regulatory requirements and internal standards to ensure continuous Inspection Readiness.
• Support the Global Head of Q&C in developing and implementing quality policy goals.
• Provide input to regular Q&C team meetings, sharing data, presentations, and recommendations.
• Collaborate cross-functionally across departments and interface with management and clients.

Quality Assurance

• Prepare, conduct, and report on internal audits (vendor, technology, and process-related).
• Conduct peer reviews of internal audit reports and oversee Corrective & Preventive Action (CAPA) Plans.
• Support external audits and inspections by regulatory authorities.

Quality Systems

• Oversee controlled document (CD) management and ensure alignment with Q&C training activities.
• Manage the day-to-day operations of the eQMS (CD & Q&C modules).
• Support continuous improvement initiatives across the Quality Management System (QMS).

Quality Issue Management

• Monitor and manage quality issues, leading investigations and Root Cause Analyses (RCA).
• Provide quality data reports and performance metrics to support informed business decisions.
• Act as the main contact for internal and external quality-related matters.

Q&C Data Analytics & Reporting

• Maintain and update Q&C data trackers.
• Deliver regular and ad-hoc data analyses and reports.

Quality Management Training

• Manage the Astrum training platform and training matrices.
• Ensure completion, compliance, and maintenance of training records in the eQMS.

• Bachelor’s or Master’s degree in a relevant field (e.g., pharmacy, biology, medicine, engineering) or equivalent qualification.
• Minimum of 3 years’ experience in quality management, ideally within clinical research or a CRO.
• Strong understanding of GCP, ICH, and other regulatory requirements.
• Proven ability to conduct audits, manage CAPAs, and perform Root Cause Analyses.
• Excellent analytical, communication, and organizational skills.
• Proficiency in English (spoken and written).
• Skilled in standard business applications and eQMS tools (e.g., MS Office, eQMS platforms).
• Self-motivated, structured, and solution-oriented with a strong teamwork mindset.
• Continuous improvement mindset with the ability to identify and implement process enhancements.

• Flexible working hours through flextime.
• Competitive salary.
• Opportunities for professional growth within a supportive and dynamic team.
• Hybrid work options and an engaging work environment.
• A culture that values your ideas for process and quality improvement.