Beschreibung

In this role, you will play a crucial part in advancing Cell Therapy by ensuring quality and compliance. Your day-to-day responsibilities will involve collaborating with teams, analyzing quality metrics, and providing guidance on GCP principles to enhance the overall quality culture.

Anforderungen

• •Strong foundation in science and quality management
• •Bachelor of Science in relevant discipline or equivalent professional experience
• •At least 4 years of operational and/or quality experience in drug development
• •Solid understanding of business processes and clinical study information systems
• •Proven time management skills
• •Experience working collaboratively with internal teams and external partners
• •Excellent written and verbal communication skills
• •Strong knowledge of international clinical trial regulations and guidelines
• •Ability to engage and collaborate across boundaries
• •Capacity to manage multiple competing priorities
• •Good understanding of Cell Therapy-specific procedures
• •Experience applying process improvement methodologies
• •Background in developing and managing business processes

Aufgaben

• •Collaborate with the BPQL team to provide expert guidance and coaching
• •Develop, track, and analyze quality metrics at a regional or country level
• •Advise SMM teams on applying GCP principles for quality standards
• •Offer compliance advice using regulatory guidance and global standards
• •Identify and recommend improvements to BPOs when necessary
• •Consult on compliance learning needs and facilitate training delivery
• •Partner with CTCO Process Owners to align SMM processes with quality standards
• •Lead quality-related initiatives and continuous improvement programs
• •Collaborate with the Director of Cell Therapy Quality Management to enhance quality culture
• •Assess training compliance of local SMM teams during oversight activities
• •Deliver onboarding and ad hoc training on quality and compliance topics
• •Share global process updates impacting local SMM team compliance
• •Facilitate resolution of compliance issues and promote best practices
• •Support investigations and approve quality events and CAPAs in VQV
• •Foster an engaging quality culture and implement compliance improvement initiatives
• •Provide consultation during RIST, inspections, and audits
• •Act as audit coordinator for internal audits and serve as SME during inspections
• •Analyze quality metrics and trends to improve performance
• •Participate in regional CT SMM leadership teams and facilitate quality review meetings
• •Identify, track, and escalate compliance risks and support risk mitigation
• •Escalate significant issues or risks to the Director of Cell Therapy Quality Management

Benefits