Clinical Quality Manager - Cell Therapy(m/w/x)

Vollzeit

Berufserfahren

Keine Angabe

Hamburg

Nejo KI-Zusammenfassung

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.

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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

Bachelor-Abschluss

Berufserfahrung

4 Jahre

Deine 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

Sprachen

Englisch – verhandlungssicher

Deine Vorteile

Weiterbildungsangebote

•Personalized development opportunities

Lockere Unternehmenskultur

•Culture of trust and appreciation
•Diverse and inclusive work environment

Modernes Büro

•Collaborative and flexible office space

Fokus auf Nachhaltigkeit

•Commitment to carbon negativity by 2030

Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens AstraZeneca GmbH erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.

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