BPM Evidence Quality Director, Us Lat/am
4 weeks ago
At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation - ultimately providing employees with the opportunity to work across teams, functions and even the globe.
Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office and BlueSky Hub in downtown Toronto are purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.
Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.
We are now recruiting a** Medical Evidence Quality Directo**r to support Latin America and US within **BioPharmaceuticals Medical (BPM).**
The Medical Evidence organization is accountable for the delivery of global strategic studies required to generate the evidence to build the confidence on AZ therapies and additional observational, interventional, and externally sponsored research required by Global Product Teams and Global Medical Teams.
A specialist/expert role for Quality and Compliance across the Medical Affairs organization in AstraZeneca. You will be responsible for implementing and maintaining Quality and Compliance strategies in alignment with AZ Code of Ethics and the Global Policies, as agreed with relevant leadership teams across the Medical Evidence organization, business/resource planning, and team leadership. Provides support to the Medical Evidence organization in selected Region/Countries, to enable individuals taking responsibility for meeting Quality and Compliance objectives in their own deliverables.
**Other responsibilities**:
- Driving the establishment and implementing policies, procedures and standards for own work and work of others, ensuring compliance with internal and external standards and regulations
- Support (sounding board) for questions regarding processes and regulations (for example, GCP)
- Support to Medical Evidence in Quality and Compliance related systems and tools
- Ensures own knowledge and knowledge of team members of standard methodologies and new relevant developments is up to date
- Interact, when applicable, with relevant Quality and Compliance functions, for example R&D Quality Assurance and Global Compliance, as well as Quality and Compliance roles in in other functions relevant to Medical Evidence deliveries.
- Responsible for the management of the Quality Management System within the Medical Evidence organization in selected Region/Countries.
- Oversight of quality related metrics in selected Region/Countries, including providing mentorship on developing and managing these, in collaboration with the Quality Metrics Coordinator
- Provide oversight and mentorship on process life cycle management for Medical Evidence process owners in selected Region/Countries
- Oversight of Quality Issues reported from Medical Evidence activities in selected Region/Countries in appropriate reporting system (e.g., VQV)
- Provide 1st line support to Medical Evidence staff and, when applicable Medical Affairs staff, in selected Region/Countries entering Risks and/or Issues in appropriate reporting system (e.g., VQV)
- Support the Medical Evidence organization in selected Region/Countries to be appropriately prepared for audits and inspections - Inspection readiness
- Oversight of continuous improvement activities - including driving relevant individual activities
- Contributes to an effective collaboration between the areas of Medical Affairs
- Interaction other Medical functions - for example, Medical Excellence, Global Payer Evidence & Pricing
**Essential for the role**
- Proven experience in pharmaceuticals or a related industry
- Strong work ethics and high integrity standards
- Knowledge and experience of corporate governance and relevant regulations, laws, and standards
- Knowledge of the overall pharmaceutical product development process, including stages of development and role of different functional areas.
- Experience in the management of observational studies and/or clinical trials
- Strong ability to work independently
- Ability to collaborate with colleagues at all levels in various geographies
- Project Management
**Desirable for the role**
- Understanding of multiple aspects within Medical Affairs
- Extensive knowledge of the latest technical and regulatory developments
- Expert knowledge of quality management and good solid understanding of GXP functions and regulations.
- Creates C
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