Clinical Quality Manager (mfd) Cell Therapy

Innovative dynamic and sustainable: As one of the worlds leading research-based pharmaceutical companies we at AstraZeneca offer the best opportunities for your personal and professional development. For us its clear: when we see a chance for change we seize it and make it happen. Because an opportunity no matter how small can be the start of something big. Delivering life-changing medicines is about being entrepreneurialfinding these moments and recognizing their potential. With us every single employee puts patients first.

Make an impact in advancing Cell Therapy by ensuring the highest standards of quality and compliance.

We are seeking a

Clinical Quality Manager (CQM) (m/f/d) - Cell Therapy

to join our Cell Therapy Clinical Operations (CTCO) team.

In this role you will collaborate with the Business Processes Quality & Learning (BPQL) team to provide expert guidance and coaching enabling the successful delivery of Cell Therapy studies by the Site Management and Monitoring (SMM) organization.

The CQM (m/f/d) is responsible for developing tracking and analyzing quality metrics at a regional or country this role you will provide guidance and advice to Site Management and Monitoring (SMM) teams on applying GCP principles ensuring their work meets the highest quality standards.

You will use regulatory guidance global standards and SOPs to offer compliance advice and identify opportunities for improvement. When needed you will recommend and communicate these improvements to Business Process & System Owners (BPOs). Additionally you will support SMM management by consulting on compliance learning needs and facilitating training delivery.

While overall accountability for quality remains with the SMM country leadership team you will work in close collaboration with them and other functions to plan and implement quality control activities effectively.

As part of the Cell Therapy Clinical Operations (CTCO) Business Processes Quality & Learning (BPQL) team you will bring specific expertise in the following areas:

• Partnering with CTCO Process Owners to ensure all established SMM processes align with global quality standards.

• Leading or contributing to quality-related initiatives and continuous improvement programs that enhance compliance within CTCO trials and processes.

• Collaborating actively with the Director Cell Therapy Quality Management to strengthen quality culture and compliance across the organization.

Typical Responsibilities

• Assess training compliance of local SMM teams as part of quality oversight activities; deliver onboarding and ad hoc training on quality and compliance topics.

• Share global process updates impacting local SMM team quality compliance in a timely manner.

• Facilitate resolution of compliance issues and promote best practices across CT SMM countries.

• Support investigations and approve reported quality events and CAPAs in Veeva Quality Vault (VQV) if applicable.

• Foster an engaging quality culture within CT SMM; develop 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 sponsor and investigator site inspections.

• Act as a key member throughout the inspection process including consultation for inspection responses.

• Analyze quality metrics and trends to improve performance and proactively manage issues.

• Participate in regional CT SMM leadership teams and facilitate quality review meetings.

• Identify track and escalate compliance risks; support risk mitigation activities and manage country quality risk registers.

• Escalate significant issues or risks to the Director Cell Therapy Quality Management.

Your Profile

You bring a strong foundation in science and quality management combined with hands-on experience in clinical operations. Ideally you have:

• A Bachelor of Science in a relevant discipline or equivalent professional experience.

• At least 4 years of operational and/or quality experience in drug development within a pharmaceutical or clinical setting.

• Solid understanding of business processes technology and clinical study information systems.

• Proven time management skills and the ability to deliver timely responses and support to internal and external stakeholders.

• Experience working successfully and collaboratively with both internal teams and external partners.

• Excellent written and verbal communication skills with the ability to influence negotiate collaborate solve problems present effectively mentor others and manage conflicts.

• Strong knowledge of international clinical trial regulations and guidelines (ICH GCP FDA EMA) and internal standards across functions.

• Ability to engage and collaborate across boundaries influence effectively and maintain a problem-solving focus.

• Capacity to manage multiple competing priorities demonstrating innovation ownership accountability and a growth mindset.

• A strong professional reputation within the business and industry.

• Good understanding of Cell Therapy-specific procedures.

• Experience applying process improvement methodologies (e.g. Lean Six Sigma) to identify root causes and drive improvements.

• Background in developing and managing business processes to enhance performance.

What You Can Look Forward To:

• An exciting pipeline and innovative products

• Personalized development opportunities with a strong focus on lifelong learning

• A culture of trust appreciation and room to contribute within a passionate team

• Office space in the heart of Hamburg designed for collaborative flexible and agile working

• A diverse inclusive and bias-free work environment committed to theCharta der Vielfalt where differences are not only welcomed but actively encouraged. We welcome and consider applications from all qualified candidates.

• A sustainable company aiming to becomecarbon negative across the entire value chain by 2030

If youre interested in this challenging and rewarding opportunity we look forward to receiving your application via our online tool!

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds with as wide a range of perspectives as possible and harnessing industry-leading skills. We believe that the more inclusive we are the better our work will be. We welcome and consider applications to join our team from all qualified candidates regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment) as well as work authorization and employment eligibility verification requirements.