Quality Assurance Officer II (Europe)

Allucent Clinical Research Organization™ is a global provider of comprehensive drug development solutions including consulting, clinical operations, biometrics, and clinical pharmacology across various therapeutic areas. With over 30 years of experience in more than 60 countries, Allucent serves small and mid-sized biotech companies, focusing on high-quality and personalized customer service.

• Life science, healthcare, and/or business degree
• Minimum 3 years of relevant work experience
• Minimum 2 years of experience in drug development and/or clinical research
• Basic knowledge of ICH-GCP (R2), auditing, GDPR/HIPAA, CFR, and other applicable regulatory requirements
• Process oriented with analytical skills
• Proficient in written and verbal communication including good command of English
• Representative, outgoing, and client focused
• Ability to work in a fast-paced, challenging environment
• Administrative excellence
• Proficiency with computer applications such as Word, Excel, and PowerPoint
• Strong organizational and time management skills

• Development and management of quality documentation such as SOPs, training, and sponsor documentation
• Co-host and may lead customer audits
• Participate in regulatory inspections
• Perform audits including process, project, vendor, and investigator site audits
• Perform quality control review of regulatory documents
• May lead quality issue, deviation investigation, follow-up, and CAPA closures
• Provide oversight management of training, maintaining curricula and administering learning management systems
• Assist in developing and delivering training materials
• Support staff learning and development
• Draft and contribute as Subject Matter Expert to evaluate and harmonize processes and procedures within the Quality Management System
• Ensure good communication and relationships with (future) clients
• May contribute to client evaluations, visits, and bid defenses
• May act as primary contact for dedicated quality areas or assignments
• Support other quality activities as directed such as RFI and vendor questionnaire, quality metrics, and CSV
• Contribute to other business areas and duties as assigned

*Allucent does not accept unsolicited resumes from third-party recruiters or uninvited collaboration requests. Unsolicited resumes to employees do not obligate Allucent to employment or remuneration. Candidates should not be submitted directly to hiring managers, employees, or HR. The in-office work policy encourages 2 days in office per week if within reasonable distance from a global office.