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 www.astellas.com.
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:
Responsible for the development and maintenance of excellence in Clinical QA (CQA) activities for Astellas sponsored programs. This position works in partnership with Medical and Development (M&D) and other business units in support of global and local drug development, registration and marketing for assigned projects across Therapeutic Areas (TAs) and for all stages of drug development.
Reports to the Senior Director, CQA and participates in the development, implementation, and successful execution of the CRQA mission, objectives and 3-5 years strategic plan.
Collaborates with relevant CRQA members and M&D for alignment with company-wide standards. Supports CQA project and/or non-project activities to ensure that M&D processes and clinical trials (Phase I-IV) are executed in compliance with the international regulatory requirements for Good Clinical Practice (GCP) and other relevant (inter)national regulations. Manages external (contract) QA resources and provides technical expertise to identify and resolve quality issues.
Essential Job Responsibilities:
* Responsible for management of process improvement initiatives. This includes the independently scheduling, scoping definition, planning, conducting and reporting of improvement projects, liaising with stakeholders as relevant. It also incorporates interpretation of findings, providing trending information, root cause analyses and identifying lessons learned for the continuous improvement of the Astellas organization.
* May represent CQA for M&D projects across Therapeutic Areas. Provides support and consultation to other CRQA functional areas as needed.
* Responsible for providing unsupervised GCP expert advice to key personnel. This includes and is not limited to
* Interpreting regulatory authorities' requirements and advising in the implementation across the Astellas organization
* Developing training materials and providing GCP training internally and externally to both small and large professional organizations. It also encompasses coaching of CQA colleagues and other functions on CQA related processes
* In case of regulatory agency inspections review of responses from operations before sending to CQA management for their final review and approval
* Follow the direction for CQA's approach in collaboration with the CQA Team and relevant M&D stakeholders locally, regionally and globally. Directs the development of this approach and its implementation to ensure an effective CQA process improvement which complies with regulatory requirements and stakeholder expectations
* Drive the development, communication, implementation, maintenance and execution of standards and processes within the function and communicates to relevant stakeholders
* Continuously evaluates and drives changes in CQA processes to meet changing needs of the organization, regulatory environment and industry best practices. Manages development and maintenance of the schedules for process improvement.
* Assures the creation and implementation of the appropriate strategic risk-based support model/processes for each project. Ensures the development of short and long-term risk-based quality and process improvement strategies in support of M&D development programs based on current regulatory interpretations, and drives their implementation locally and globally as appropriate
* 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 providing the quality input to ensure that the appropriate processes and procedures are in place for C(R)QA.
* Responsible for quality support to development programs and submissions by establishing strong collaborative relationships with internal stakeholders and functions, as well as of relevant external stakeholders.
* Drives consistency across projects, processes and organization by (not limited to):
* Leading process improvement and operational excellence activities across CRQA and M&D 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 M&D business processes.
* Directly manages 1-3 process improvement initiatives, depending on the complexity
* Functional Service Provider (FSP)/Vendor governance support for up to 3 FSP relationships
* Supports the development and execution of inspection readiness plans of approximately 1-3/annum for regulatory agency inspections related to MAA / NDA submissions
* Responsible for supporting regulatory agency inspections of GCP activities and ensuring inspection readiness with an average of 3 inspections/annum
* Reports to the Senior Director/Director/Associate Director, CQA
* Peers include CRQA Senior Managers, and other global and regional M&D Team Managers of other functions such as Finance, Legal, Internal Audits, Ethics & Compliance, etc.
* Collaborates directly with M&D to achieve common objectives
* Bachelor's degree; advanced degree preferred.
* Minimum of 5 years in pharmaceutical, biotechnology, or related industry
* Minimum of 3 years significant experience in Clinical Quality Assurance
* Minimum of 3 years project management experience, preferably in a highly matrixed, multicultural global setting, requiring facilitation, negotiation, problem-solving, and conflict resolution skills
* In-depth understanding of GCP requirements for both marketed and investigational products
* Solid understanding of CRQA processes
* Effective oral and written communication and presentation skills in English and/or Japanese
* Demonstrated competence to build strong working relationships with colleagues and stakeholders
* Practical experience and understanding of clinical quality assurance as applied throughout the entire pharmaceutical compound/product life cycle
* Proficiency in Microsoft Office
* Demonstrated ability to proactively predict, generate insights and resolve complex problems, think strategically and tactically, generate solutions to complex problems and build consensus across the global organization
* Domestic and international travel at 10-25% as required
* Medical, Dental and Vision Insurance
* Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
* 401(k) match and annual company contribution
* Company paid life insurance
* Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
* Long Term Incentive Plan for eligible positions
* Referral bonus program
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
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