Clinical Quality Associate Director - Oncology (CQAD)

Clinical Quality Associate Director - Oncology

Location: Horizon Place, Luton

Competitive salary and benefits

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering ground-breaking methods and bringing unexpected teams together. Interested? Come and join our journey.

The Clinical Quality Associate Director (CQAD) in general, is responsible for the maintenance and further development, and the communication of high-quality standards in the delivery of clinical studies. This includes a key role in ensuring that the training needs in the local SMM (Site Management & Monitoring) team are fulfilled in cooperation with the local SMM leadership team.

The CQAD provides compliance and process advice to their local SMM team and identifies opportunities for quality and process improvements on local, regional and global level.  

The CQAD is responsible for the development, implementation and continuous review of local procedural documents, and maintains current knowledge and understanding of local regulations and industry practices in relation to clinical trials.

The CQAD supports audits and inspections and is the main contact for auditors for the local SMM team. 

The CQAD supports the local SMM leadership team in the planning and implementation of all quality control activities and uses risk management to evaluate compliance issues and develop solutions.  The CQAD keeps abreast of any business compliance issues and works in close collaboration with Regional Director, Clinical Quality SMM (RDCQ) and any key regional and global networks.

A CQAD may take on additional responsibilities or other roles such as LSAD or line manager (Director, SMM), or key global/regional assignments as agreed with local and/or regional SMM Leadership.

Typical accountabilities:

• Provides advice to Local Study Teams on AZ procedural framework including global clinical processes, procedural documents, applicable Quality & Compliance manual documents, and on international guidelines such as ICH-GCP, industry standards and local regulations.

• Provides competent advice on local regulations related to clinical trials, keeps abreast of changes in local regulations related to clinical trials and keeps local teams and local processes updated.

• Ownership of local procedural framework.

• Supports local management in the planning and conduct of local quality control activities as described in the local annual quality plan, including performing accompanied site visits. Performs any required QC visits / QC activities with local staff and maintains the annual quality plan updated.

• Provides local management with information regarding status of quality observed in the local SMM.

• Collaborates with and supports local study teams to resolve quality and compliance issues.

• Reviews regularly Protocol Deviations and ensures Quality Issues are reported within the appropriate timelines to local Authorities and in AZ internal review systems according to AZ QI process.

• Supports the local organisation in the preparation for, conduct of and responses to audits and regulatory inspections.

• Advises Local Study Teams on the resolution of the findings in audit and inspection reports. Gives regular feedback on audit and inspection findings to relevant SMM staff.

• Shares takeaways from local audits and inspections with local staff and with regional CQAD network, shares global/regional findings with local staff.

• Identifies and ensures resolution of potential risks based on previous study/systems QC results, audit and inspection results and current routine quality management work.

• Is a key contact in the evaluation and management of fraud/poor quality cases, communicating with Quality Assurance (QA), RDCQRDCQand local management, as required.

• Identifies and organises/provides on-going and ad hoc training of local staff according to local training needs, in cooperation with local SMM leadership: ▪ introductory training to new staff, including Procedural Training.

• Ad hoc local training solutions e.g., as result of serious or recurring quality issues.

• Is involved in other local initiatives to identify and share standard methodologies.

• Supports implementation of global procedures and systems on local level by: ▪ providing review comments to global procedural documents where requested.

• Assessing if global training material is adequate for local use, providing input/comments to global training material authors, if required.

• Organising/providing local face to face training for global procedures and systems, if required.

• Collecting and advancing process/systems related questions from users.

• Providing required training relating to relevant global initiatives.

Essential requirements:

• Bachelor degree in related field, preferably in life science, or equivalent qualification

• Significant experience in the pharmaceutical industry, preferably in Development Operations/Quality Assurance.

• Good knowledge of international guidelines ICH-GCP as well as relevant local regulations.

• Good understanding of the drug development process and related GXP activities.

• Good understanding of the skills and knowledge required for the successful delivery of a clinical study, e.g., ICH-GCP, study management, site management, monitoring.

• Excellent organisational skills.

• Excellent verbal and written communication skills.

• Excellent ability to prioritize and handle multiple tasks.

• Excellent attention to details.

• Good presentation skills.

• Integrity and high ethical standard.

• Manages change with a positive approach for self, team and the business. Sees change as an opportunity to improve performance and add value to the business.

• Excellent knowledge of spoken and written English.

• Ability to travel nationally and internationally as required.

Desirable requirements:

• Ability to interact widely and effectively within the company at all levels.

• Ability to work in an environment of remote collaborators.

• Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.

• Good analytical, problem solving, negotiation and conflict resolution skills.

• Demonstrated ability to set and manage priorities, performance targets and project initiatives in a global and regional environment.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible! We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world!

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 authorisation and employment eligibility verification requirements.