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Clinical Quality Associate Director

Plats Istanbul, İstanbul, Turkiet Ankara, Ankara, Turkiet Adana, Adana, Turkiet Jobb-id R-124222 Datum inlagd 11/22/2021

At AstraZeneca, we unlock the power of what science can do. Empowered to explore, everyday we work towards our ultimate aim – treating, preventing, modifying and even curing complex diseases. With an unwavering belief in following the science, we unleash our curiosity. Investing in key areas, harnessing innovative technologies and taking smart risks. Help to shape the future of healthcare as we take our pipeline from strength to strength. Embrace an environment built on lifelong learning. Never complacent, we seek opportunities to expand our knowledge. The place to build a long-term meaningful career. Here we get to develop and grow – whether that’s working at the leading-edge or on varied stages and molecules. Working on things that have never been done before. In return, when great science comes alive, we have the opportunity to get published. We stand together behind a shared ambition. United by our collective passion for having a positive impact on patients’ lives. Important work that is both meaningful and fulfilling. With the potential to reach over a billion patients across the globe who are living with these complex diseases.

Background & Qualifications

* For permanent employees, having minimum 1 year of AstaZeneca experience,

* University degree, preferably from Healthcare related areas (Pharmacy, Chemistry, Biology, Medical etc. Faculties),

* Advanced level of English,

· Minimum 5 years experience in the pharmaceutical industry, preferably in Clinical Development/ Quality Assurance

* Strong communication and negotiation skills,

* Ability to prioritize and handle multiple tasks,

* Basic coaching skills and good at team work,

* Effective planning and organizational skills with result-oriented approach,

* Stakeholder management experience,

* Analytical thinking, critical reasoning ability,

* Good command of MS Office applications,

* No restriction to travel,

* Driving License,

* No military obligation for male candidates.

Summary Job Description

* Reporting directly to Director, Country Head

* Provide advice to Local Study Teams and MEA contacts on global clinical processes, procedural documents, applicable Quality & Compliance manual documents, international guidelines such as ICH/GCP and local regulations, as applicable

* Provides competent advise to Local Study Teams on local regulations related to clinical trials, keep abreast of changes in local regulations related to clinical trials and keep local teams and processes updated

* Responsible for planning and conduct of local quality control activities.

* Collaborate with and support local study teams and MEA contacts to resolve quality and compliance problems

* Support the local organisation and MEA contacts in the preparation for and responses to audits and regulatory inspections.

* A key contact in the evaluation and management of fraud/poor quality cases, communicating with QA

* Identify and organise/provide on-going and ad hoc training of MEA staff according to training needs, in cooperation with SM&M leadership

* Co-ordinate the development, publication, training, implementation, maintenance and archiving of Local Procedural Documents, ensuring that they comply with global Clinical Procedural Documents, applicable Quality & Compliance Manual documents, international guidelines such as ICH/GCP and local regulations

Why AstraZeneca?

A high performing team, we work hard to not just meet but go beyond the needs of patients and the wider healthcare industry We leverage our partnerships with external experts across the industry, to create and communicate evidence that changes medical practice. As a partner for many, we effectively communicate complex ideas whilst seeking to understand ever-changing needs and requirements. Our valuable contribution and scientific expertise is responsible for advancing our pipeline and accelerating our pathway to finding a cure. Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.

Where can I find out more?

Follow AstraZeneca on LinkedIn

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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.

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