Senior Manager Clinical Quality Assurance (GCP)
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at [Register to View] .
This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.
Purpose and Scope:
The ideal candidate will be responsible for the development and maintenance of excellence in Clinical Quality Assurance activities for Astellas sponsored programs. This position works in partnership with Medical and Development and other business units in support of global and local drug development, registration and marketing for assigned projects across Therapeutic Areas for all stages of drug development.
Essential Job Responsibilities:
Responsible for the management of multiple regional, cross regional and/or global audits. This includes the independently scheduling, scoping definition, planning, conducting and reporting of audits, liaising with stakeholders on audit findings and the follow up thereof. It also incorporates interpretation of findings, providing trending information, root cause analyses and identifying lessons learned for the continuous improvement of the Astellas organization. Manages and follows up on findings and improvement areas.
Responsible for providing unsupervised Good Clinical Practice expert advice to key personnel. This includes and is not limited to:
- Developing training materials and providing Good Clinical Practice training internally and externally to both small and large professional organizations. It also encompasses coaching of Clinical Quality Assurance colleagues and other functions on Clinical Quality Assurance related processes
- In case of regulatory agency inspections, review of responses from operations before sending to Clinical Quality Assurance management for their final review and approval
- Interpreting regulatory authorities’ requirements and advising in the implementation across the Astellas organization.
Responsible for regulatory inspection preparation at Astellas entities and/or partners across the region and globally. Analyzes the risks, defines the strategy for inspection readiness and manages the rollout of the inspection readiness program across departments and territories, ensuring a harmonized approach.
Responsible for identifying outsourcing needs, selecting, managing and evaluating 3rd party QA service providers of which audit and/or consultancy activities have been outsourced. This includes providing training, managing financial information and maintaining effective interfaces to ensure that outputs meet the defined expectations in terms of quality, content and timelines.
Supports the development, improvement and maintenance of the Astellas Quality System by identifying root causes to non-conformances related to the processes and/or systems, and by addressing observed gaps in these processes and systems. This includes research of the Pharma Market Place / Quality Assurance organizations, Regulatory developments and Inspection reports to ensure Astellas meets its strategic objectives in terms of Quality, Business Model and Effectiveness.
Manages or supports Good Clinical Practice inspections. This includes communication with Regulatory Authorities, Inspection preparation, inspection hosting, support of corrective and Preventive Action generation and monitoring of follow up to ensure that any risk / nonconformance as identified by inspectors/investigators is adequately addressed and mitigated
Develops and manages interfaces with Quality Assurance departments of service providers, to ensure Quality Assurance oversight of the service provider and that any risk to Astellas business is being mitigated
Drives consistency across projects, processes and organization by (not limited to):
- Leading process improvement and operational excellence activities across Clinical Regulatory Quality Assurance and Medical & Development functions.
- Supporting and executing Due Diligence and/or post acquisition activities.
- Enhancing stakeholder relationship to ensure compliance and consistency of regulate activities and associated processes.
- Driving trending and metrics across studies and Medical & Development business processes.