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Astellas Pharma Senior Manager, Clinical Quality Assurance in Northbrook, Illinois

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 Area(s) (TAs) for all stages of drug development.

Reports to the Senior Director/Director/Associate Director, CQA and contributes to 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 projects and/or non-project activities to ensure that M&D processes and clinical trials (Phase I-IV) are executed in compliance with the international requirements for Good Clinical Practice (GCP) and other relevant (inter)national regulations. Responsible for managing, conducting and/or participating in regional/global audits. Manages external (contract) QA resources and provides technical expertise to identify and resolve quality issues.

Essential Job Responsibilities:

  • Responsible for the management of multiple regional, cross regional and/or global audit programs. 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.

  • May represent CQA as a Global Quality Lead (GQL) for M&D projects across Therapeutic Areas. Provides support and consultation to other CRQA functional areas as needed 3. Responsible for providing unsupervised GCP expert advice to key personnel. This includes and is not limited to:

  • 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

  • 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 roll out 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 / QA organizations, Regulatory developments and Inspection reports to ensure Astellas meets its strategic objectives in terms of Quality, Business Model and Effectiveness

  • Manages quality issues related to critical nonconformances, suspicion of scientific misconduct and/or potential fraud. Leads proper corrective and preventive actions identification and rolls out and ensures follow up with effectiveness measures

  • Manages or supports GCP inspections. This includes communication with Regulatory Authorities, Inspection preparation, inspection hosting, support of CAPA 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 QA departments of service providers, to ensure QA 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 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

Quantitative Dimensions:

  • Annual auditing of approximately 15-30 regional/global audits, depending on the complexity

  • Functional Service Provider/Vendor governance support for up to 3 FSP/Vendor relationships

  • Responsible for 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.

Organizational Context:

  • 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

Qualifications:

Required

  • Bachelor's degree

  • Minimum of 5 years in pharmaceutical, biotechnology, or related industry

  • Minimum of 2 years significant experience in Clinical Quality Assurance

  • Minimum of 2 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

  • Practical experience and understanding of clinical quality assurance as applied throughout the entire pharmaceutical compound/product life cycle

  • Effective oral and written communication and presentation skills in English and/or Japanese

  • Solid understanding of CRQA processes

  • Proficiency in Microsoft Office

  • Domestic and international travel at 10-25% as required

Preferred

  • Advanced degree in related disciplines

  • Preferred location for this position is Northbrook (IL) - United Stated, Leiden - The Netherlands, Tokyo - Japan

Benefits:

  • 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

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Category Quality Assurance/Quality Control

Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans

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