Clinical Quality Associate Director

仕事内容

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.

In partnership countries this role provides clinical quality management activities and typical accountabilities, to SMM BioPharmaceuticals and to SMM Oncology local teams

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.

CQADs might have different internal titles based on the experience level (CQAD, Senior CQAD). The experience level depends on the years of experience, performance record, level of independence in the role, ability to take on additional tasks or tutor more junior colleagues. The Director Country Head/ Senior Director Country Head may assign this internal title after confirmation with Senior Director, Cluster Head/Executive Director l Regional Head SMM.

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 learnings from local audits and inspections with local staff and with regional CQAD network, shares global/regional learnings 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 best practices.

• 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 escalating process/systems related questions from users.

▪ Providing required training relating to relevant global initiatives.

• 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.
• Coordinates the development, publication, training, implementation, maintenance and archiving of Local Procedural Documents, ensuring compliance with global Clinical Procedural Documents, applicable Quality & Compliance Manual documents, international guidelines such as ICH-GCP and local regulations.
• Acts as interface to/contact for QA.
• When needed, escalates related questions to RDCQ, QA, Process Owners, as appropriate.
• Acts as interface with local stakeholders: legal advice, nominated signatory, GxP function for quality related topics.
• Cascades to local clinical organization any relevant new global developments, initiatives and information coming from other stakeholders: e.g., RDCQ, QA.
• Participates in and contributes to the Clinical Quality Associate Directors’ Network in their region, as applicable.
• Is involved in local regulatory or operational external experts’ groups, as required on country level.
• Provides support, if required, to global teams in case of issues occurring in globally outsourced studies: support to local IEC clarifications, Insurance policy issues, serious breaches etc.
• Provides training to Investigational Site staff on ICH-GCP and local regulations if support is required.
  
  

Essential

• Bachelor degree in related discipline, preferably in life science, or equivalent qualification.
• At least 5 years of 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.
• Good ability to learn and to adapt to work with IT systems.
• Ability to travel nationally and internationally as required.