Clinical Quality Manager (m/f/d) - Cell Therapy
AstraZeneca
Pharmazeutische Industrie
Hamburg (Ohlsdorf) - Deutschland
Senior Fachkraft / Projektleiter
Experteer Overview
In this role you ensure high-quality, compliant Cell Therapy studies by guiding Site Management and Monitoring teams and collaborating with BPQL. You develop and monitor quality metrics regionally, applying GCP standards and regulatory guidance to drive improvements. You contribute to a strong quality culture and support training, audits, and risk management. This opportunity lets you influence CTCO processes at a global level within a mission-driven, patient-centered organization.
Leistungen / Benefits
- pipeline and innovative products
- personal development opportunities
- culture of trust and collaboration
- Hamburg office for collaborative work
- diverse and inclusive environment
- sustainability goals (carbon negative by 2030)
Verantwortungsbereiche
- Develop, track and analyze quality metrics at regional/country level.
- Provide guidance to SMM teams on applying GCP and quality standards.
- Use regulatory guidance, global standards and SOPs to offer compliance advice and identify improvements.
- Coordinate with Business Process & System Owners (BPOs) to implement improvements.
- Assess training compliance and deliver quality/compliance training.
- Facilitate timely updates on global processes impacting local SMM quality.
- Lead or contribute to quality initiatives and continuous improvement within CTCO.
- Support investigations and approve CAPAs in Veeva Quality Vault (VQV) where applicable.
- Foster a quality culture and implement compliance improvement initiatives.
- Provide country-level consultation during inspections and audits; act as audit coordinator and SME during site inspections.
- Lead quality reviews and risk management, including maintaining country quality risk registers.
- Escalate significant issues to CTQ management and support remediation actions.
Zentrale Anforderungen
- Bachelor of Science in a relevant discipline; or equivalent professional experience
- Minimum 4 years of operational and/or quality experience in drug development
- Solid understanding of business processes, technology and clinical study information systems
- Proven ability to communicate effectively with internal and external stakeholders
- Experience collaborating with internal teams and external partners
- Strong written and verbal communication skills; ability to influence, negotiate, and mentor
- Solid knowledge of international clinical trial regulations and guidelines (ICH GCP, FDA, EMA) and internal standards
- Ability to work across boundaries, influence and solve problems while managing multiple priorities
- Strong professional reputation within the business and industry
- Good understanding of Cell Therapy procedures
- Experience applying process improvement methodologies (e.g., Lean Six Sigma) and developing business processes to boost performance
Stellenbeschreibung
In this role you ensure high-quality, compliant Cell Therapy studies by guiding Site Management and Monitoring teams and collaborating with …
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Clinical Quality Manager (m/f/d) - Cell Therapy
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