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. 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.
The Clinical Quality Associate Director (CQAD) is responsible for the maintenance, development, and 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 Site Management & Monitoring (SMM) 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 levels.
The CQAD is responsible for the development, implementation, and continuous review of local procedural documents, and maintains current knowledge 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 closely with the Regional Director, Clinical Quality SMM (RDCQ) and key regional and global networks.
A CQAD may take on additional responsibilities or 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 international guidelines such as ICH-GCP, industry standards, and local regulations.
* Provides competent advice on local regulations related to clinical trials and keeps local teams updated on changes.
* 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.
* Provides local management with information regarding the status of quality observed in the local SMM.
* Collaborates with and supports local study teams to resolve quality and compliance issues.
* Reviews Protocol Deviations and ensures Quality Issues are reported within the appropriate timelines to local Authorities and in AZ internal review systems.
* Supports the local organization in the preparation for, conduct of, and responses to audits and regulatory inspections.
* Advises Local Study Teams on the resolution of findings in audit and inspection reports.
* Shares takeaways from local audits and inspections with local staff and with the regional CQAD network.
* Identifies and ensures resolution of potential risks based on study/systems QC results, audit and inspection results, and current quality management work.
* Is a key contact in the evaluation and management of fraud/poor quality cases, communicating with Quality Assurance (QA), RDCQ, and local management as required.
* Identifies and organizes/provides ongoing and ad hoc training of local staff according to local training needs.
* Involved in local initiatives to identify and share standard methodologies.
* Supports implementation of global procedures and systems on a local level.
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.
* Excellent organizational, verbal and written communication skills.
* Ability to prioritize and handle multiple tasks with attention to detail.
* Integrity and high ethical standards.
* 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.
* Good analytical, problem-solving, negotiation, and conflict resolution skills.
So, what’s next?
Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.
#J-18808-Ljbffr