Quality Manager Regional Distribution

2 semanas atrás

Sao Paulo, Brasil AstraZeneca Tempo inteiro

AstraZeneca is one of the most fascinating biopharmaceutical companies in the world. From researchers to sales people, from lab technicians to the legal department, we all have a mission to turn ideas into science, science into revolutionary medicines that save and extend patients’; lives and benefit society. Our portfolio is solid and our pipeline is innovative with a focus on biological medicines in the Cardio-Metabolic, Respiratory and Oncology areas.

**Quality Manager Regional Distribution**

Responsible for the execution of the Quality Assurance distribution process and Quality management enablement in the region. Responsibilities include execution and continuous improvement of quality management system, oversight of quality performance, issue handling, support to GMP/GDP capability development on distribution process and at distributors.

**What you'll do**:
Support implementation of AZ Global Standard for GMP and GDP
- Train and educate stakeholders of GDP/GMP
- Implementation of Distributor Management Framework and ensuring that distributors are authorised/licensed to conduct business related to AZ products
- Implementation and monitoring of processes related to handling of AZ products
- Identifying risks and setting Corrective actions
- Monitoring Quality Performance among carriers, Distributors and DCs
- Supporting qualification of multiple cold chain solutions and associated change control
- Introducing new storage and distribution facilities
- Establishing and executing a robust rapid response process for responding to TE and S&L incidents during distribution of AZ products
- Having the capacity/time to perform and document robust Quality Risk Assessment as we will inevitably need to deviate on occasion from standard process
- Conduct activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to GDP/GMP role.
- Complete all required training on SABA, Code of Conduct, supporting Policies, and SOPs on time.
- Report potential issues of non-compliance.
- Ensure and monitor compliance by team members and third parties

**Essential Skills & Experience**
- Holding a bachelor’s degree in scientific / technical field
- Experience within the Pharma industry within Operations and/or Quality assurance.
- Proven leadership and project management /implementation experience record.
- Strong demonstrated knowledge of cGMPs/GDPs, Quality Systems and the

pharmaceutical supply chain
- Proven decision-making skills, judgement, and problem-solving skills
- Demonstrated ability to work independently and collaboratively on multidisciplinary and multifunctional teams in the Region and globally
- Strong communication and technical writing skills
- Ability to travel as required approximately 10- 20% of their time.

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