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Senior Manager, Quality & Process Operations Strategy

Astellas Pharmaceuticals – Northbrook, IL

Senior Manager, Quality & Process Operations Strategy

Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture.

There s something special about working at Astellas. It s reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.

Astellas is announcing a Senior Quality & Process Operations Strategy Manager opportunity in Northbrook or Leiden.

Purpose & Scope

Operational Improvement & Reporting Excellence is a leader in aligning functions across M&D organizations in areas which impact quality management; process management; non-drug initiative management, including IT components, to support business strategy; business information reporting and analytics; resource management; and learning and development. As Senior Quality & Process Operations Strategy Manager, this position will be responsible for providing support for cross-functional quality and process operational initiatives through collaborative partnerships with cross-functional stakeholders.

This position is responsible for supporting quality and process improvement projects within M&D by understanding business processes and cross-functional implications for any process improvement requests and changes. The position is responsible for identifying quality trends in the business and collaborating with functional management to ensure risk-managed solutions are implemented in a timely manner.

Essential Job Responsibilities

  • Support continuous improvement initiatives to sustain the Global Quality Document Maintenance Model driving operational excellence, continuous improvement, sustainability and consistent application of QD standards.
  • Support cross-functional stakeholders through the development and implementation of improved Quality documents to support consistent application of GCP processes.
  • Partner with subject matter experts to identify, share and incorporate best practices into future iterations of processes, tools, training and/or guidance.
  • Partner with CRQA to identify areas of business risk and work collaboratively to prioritize high risks and develop mitigation strategies to reduce the risk.
  • Support the business to ensure consistent application of Quality by Design principles.
  • Support the business in performing effective root cause analyses to ensure appropriate CAPA resolution.
  • Develop and communicate metrics to support proactive quality management in the business.
  • Participate in internal and external quality review activities.
  • Performs Clinical Quality Management compliance assessments/investigations.
  • Perform cross-functionally to understand organizational needs, complete gap analyses, enable process development, and conceptualize as well as implement best practice opportunities.

Quantitative Dimensions

Responsible for assisting in the evaluation of continuous improvement opportunities to increase compliance with internal SOPs and external GCP regulations. Responsible for identifying quality metrics for clinical trials.

Organizational Context

Reports to the Head of Quality & Process Operations Strategy. Collaborates with cross-functional peers and subject matter experts to drive quality and process strategies forward.





  • Associate Degree or equivalent work experience


  • Minimum 8 years in the drug development setting with a minimum of 4 years in Quality and/or Process Management or clinical/data operations.
  • Understanding of the global drug development processes, quality management principles and standard operating procedures.
  • Excellent oral and written communication and presentation skills, in English, with an ability to interact at all levels of personnel.
  • Experience working cross-functionally and cross-culturally in support of quality management and business processes, especially as they impact and influence multiple departments and levels of management.
  • Strong analytical and problem solving skills.
  • Demonstrated ability to prioritize multiple projects efficiently.
  • May require up to 10% international travel.


  • BA/BS, MS or PhD or equivalent
  • Experience with development of Quality Health dashboards
  • Working knowledge of GMP and GLP requirements


Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
Type Full-time
Location IL, Northbrook
Category Medical & Development

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