• Provides advice to DO staff 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 DO.

• Collaborates with and supports DO staff 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, self-verification, inspection readiness and regulatory inspections.

• Advises DO staff on the resolution of the findings in audit and inspection reports. Gives regular feedback on audit and inspection findings to relevant DO staff.

• Shares learnings from local audits and inspections with local staff and with CQM network, shares global 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) and 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 DO 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 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. QA.

• Participates and contributes in the Clinical Quality Managers’ Network, 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.

• Bachelors 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.

(*) to be adapted to local country market needs.

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.

阿斯利康是一家提供平等机会的企业，我们将考虑所有符合条件的求职者就业。不因残疾、性别或性取向、怀孕或产假状况、种族或民族或族裔出身、年龄、宗教或信仰、性别认同或变更、婚姻或伴侣关系、受保护的退伍军人身份（如果适用）及任何其他受法律保护的特征而产生歧视。