Job Description
At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person. At the heart of AstraZeneca, our team is committed and encouraged to follow the science. Driven by our curiosity, passion, and determination, we are paving the way to change the practice of medicine in Oncology.
The Oncology Clinical Quality Director (O-CQD) will be responsible for the management and oversight of the Oncology Clinical Quality Associate Directors (O-CQADs) in the SMM Oncology Regional Hubs. In addition to the managerial responsibilities, this individual would also act as the O-CQAD role in their country.
Typical Accountabilities
- Provides expert quality advice and coaching to direct team and site management and monitoring teams on complex matters. This can include identifying risks and crafting and recommending compliance improvement strategies, initiatives, and plans.
- Supporting local teams in driving a quality mindset and culture, resolution on sophisticated quality matters (e.g. serious breaches, fraud and poor quality)
- Identifies and communicates key compliance relevant information on country and regional quality performance as part of the Quality Management Review with the aim of developing and supporting a continuous improvement mindset.
- Actively seeks, engages, and lead collaborations within the SMM Quality network (within Oncology and other therapeutic areas) to build effective and sustainable resolution for issues.
- Identify and consolidate risks within country or region, escalate as required and define, support, and lead all aspects of the management of risk mitigation activities.
- Provides advice on AZ procedural framework including global clinical processes, procedural documents, applicable Quality & Compliance manual documents, and on international guidelines. This would include ICH-GCP, industry standards and local regulations.
- Provides senior level advice on local regulations related to clinical trials, keeps abreast of changes in local regulations related to clinical trials and ensures that teams and processes are updated.
- Shares learnings from local audits and inspections with local staff and with regional SMM Quality Network, shares global/regional learnings with local, regional and global staff.
- Identifies and organises/provides ongoing and ad hoc training & re-trainings of local staff according to local training needs, in cooperation with local SMM leadership.
- Contributes to the local implementation of systems and tools related to the delivery of clinical operational tasks or SOPs, ICH-GCP requirements, e.g. CTMS, eTMF, LMS, Toolboxes, reporting tools and dashboards, etc.
- Acts as interface with local stakeholders: legal advice, nominated signatory, GxP function for quality related topics.
- Is involved in local regulatory or operational external experts’ groups, as required on country level.
- Provides training to Investigational Site staff on ICH-GCP and local regulations if support is required.
- Bachelors Degree Required
- In depth-knowledge and broad experience within the pharmaceutical industry, GxP regulated environment.
- Excellent communication skills with a proven track record to effectively network cross functionally and globally.
- Strong risk-based decision-making skills.
- Excellent understanding of the drug development process, related GxP activities, and successful delivery of a clinical study. E.g. ICH0GCP, study management.
- Excellent knowledge of international regulations and guidelines
- Good analytical, problem solving, negotiation and conflict resolution skills. Ability to multi-task.
- Demonstrated ability to set and manage priorities, performance targets and project initiatives in a global environment.
- Ability to collaborate proactively, deal with ambiguity, ability to build strong customer relationships and strategic working partnerships to operate across multiple domains enabling process and system harmonization and standardization.
- Preferred previous experience in clinical research as a quality assurance auditor.
- Preferably an advanced degree in biological, life sciences or a related discipline.
Why AstraZeneca?
Our purpose is ambitious and so is our approach. Becoming a more agile and innovative company means building a dynamic, inspiring culture where we celebrate forward thinking and act with a sense of urgency. We are ambitious, take informed risks and learn from both success and failure. We are curious, creative and open to new ideas and ways of working. Above all, we are passionate about science and driven to always put patients first. Are you ready to move forward in your career?
What’s next.
Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you. We will go through the applications continuously so please apply as soon as possible.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
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