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

Vollzeit

Berufserfahren

Keine Angabe

Hamburg

Nejo KI-Zusammenfassung

As a Clinical Quality Manager in Cell Therapy, you will play a vital role in ensuring compliance and quality standards. Your day-to-day responsibilities will involve collaborating with teams, analyzing quality metrics, and facilitating training to enhance the quality culture across the organization.

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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
•Strong professional reputation within the business and industry
•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 to ensure high-quality standards
•Offer compliance advice using regulatory guidance, global standards, and SOPs
•Identify and recommend improvements to BPOs when necessary
•Consult on compliance learning needs and facilitate training delivery for SMM management
•Plan and implement quality control activities in collaboration with SMM country leadership
•Ensure SMM processes align with global quality standards in partnership with CTCO Process Owners
•Lead or contribute to 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 as part of quality oversight
•Deliver onboarding and ad hoc training on quality and compliance topics
•Share global process updates impacting local SMM team quality compliance
•Facilitate resolution of compliance issues and promote best practices across CT SMM countries
•Support investigations and approve reported quality events and CAPAs in VQV, if applicable
•Foster an engaging quality culture within CT SMM and implement compliance improvement initiatives
•Provide country-level 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 and manage issues proactively
•Participate in regional CT SMM leadership teams and facilitate quality review meetings
•Identify, track, and escalate compliance risks while supporting risk mitigation activities
•Manage country quality risk registers and escalate significant issues to the Director

Sprachen

Englisch – verhandlungssicher

Deine Vorteile

Weiterbildungsangebote

•Personalized development opportunities

Modernes Büro

•Collaborative office space

Lockere Unternehmenskultur

•Diverse and inclusive work environment

Fokus auf Nachhaltigkeit

•Commitment to sustainability

Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens AstraZeneca 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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