OBU Medical Evidence Delivery Process & Compliance Associate Director
The Medical Evidence Delivery Operations within the Oncology Business Unit (OBU) is responsible for the operational delivery of interventional and observational AstraZeneca sponsored studies (AZ studies), externally sponsored scientific research (ESR) and early access programs (EAP) in order to generate the evidence to build confidence in and provide access to AstraZeneca therapies for patients in need.
The Process & Compliance Associate Director (PCAD) role is responsible for evaluating efficiencies of established processes and systems, identifying areas for improvement and developing improvement strategy as well as facilitate change in line with AZ Code of Ethics, Global Policies, and as agreed with the OBU Evidence Delivery Leadership Team (OBU EDLT). The PCAD provides direction and advice on how to use the business processes and existing systems to OBU EDT personnel, and as applicable the wider OBU organization in AstraZeneca, to enable the delivery of its portfolio according to agreed high quality standards and processes toward the goal of inspection-readiness status.
The role will collaborate across OBU, BBU and R&D, both global and local teams to ensure alignment across the business, streamlined collaboration and communication, and that Evidence Delivery Team (EDT) and its portfolio comply with all relevant company and industry regulations and standards. Additionally the PCAD will ensure adherence to AstraZeneca Policies, SOPs and guidelines and present regular assessment of the key process and compliance metrics on all activities to the OBU EDLT (e.g. regular process and compliance reports).
Analyse efficiency of existing processes and oversee implementation of changed and/or new business processes
Produce process and compliance reports and communicate proactively the areas of improvement to the EDLT along with the proposed solutions
Utilize global SOPs, processes, procedures, technology and training frameworks to provide process and compliance advice to OBU EDT personnel, identify and communicate improvement opportunities to the Process and System Owners
Provide advice to study teams on global clinical processes, procedural documents, applicable quality and compliance documents, international guidelines such as ICH/GCP or external regulation
Support the OBU EDT personnel in addressing process related Quality Issues and questions related to processes and regulations to minimise/avoid QIs in future
Identify issues/trends impacting quality and/or integrity of the OBU EDT portfolio, conduct root cause analysis as appropriate and propose response strategies to address issues
Induce Inspection readiness – support the OBU EDT to be appropriately prepared for audits and inspections; collaborate with OBU EDTLT and QA department to ensure the hubs are inspection ready and support EDT-related audits and inspections
Lead and/or participate in process/quality improvement initiatives
May conduct internal process investigations/audits and use risk management to evaluate compliance issues and develop solutions
Validate and/or create & maintain the key process & compliance metrics for the OBU Evidence Delivery Team and each activity type to enable reliable performance assessment
Oversee process & compliance related metrics, systems and tools including providing guidance on developing and managing them
Review regularly and make necessary updates to relevant training grids for OBU EDT staff
Several years’ experience working within a Pharmaceutical organisation or CRO
Strong work ethics and high integrity standards
Knowledge of the overall pharmaceutical product development process, including stages of development and role of various functional areas
Knowledge and experience of corporate governance and relevant regulations, laws and standards
Knowledge of the management of observational studies and/or clinical trials
University degree (or equivalent) in business and or/sciences
Previous work experience involving Process/Compliance and/or Quality Management
Experience of communicating complex information at a senior level both verbally and written
Knowledge of Lean / Agile methodologies
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.