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Astellas Pharma Manager, Quality & Process Operations Strategy in Northbrook, Illinois

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 Quality & Process Operations Strategy Manager position located in Northbrook, IL.

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 a 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 writing simplified cross-functional quality documents [e.g. policies, standard operating procedures (SOPs), and other working practice or associated guidance documents], and creating process maps based on these QDs. This includes applying consistent QD and process model standards, consistently mapping process activities and ensuring integration with all processes in scope.

Essential Job Responsibilities:

  • Support enterprise-level initiatives, including effective and efficient QD development/revision in Microsoft Word and/or Excel, and process mapping in Microsoft Visio and/or Casewise Business Process Modeling (BPM) software.

  • Prepare professional level technical writing deliverables aligned with global QD standards, Good Clinical Practice (GCP), Quality, Regulatory and Non-Regulatory criteria expectations, and Document Impact Assessments.

  • Independently develop process maps based on QDs within the end-to-end (E2E) Process Model. 

  • Actively participate in meetings with functional SMEs to support QD development/revision and process model development/maintenance, and communicate potential QD/process gaps, as appropriate.

  • Support E2E Process Model maintenance in alignment with model architecture standardsand incorporation of updates based on identified QD and process changes.

  • Support the business in performing effective root cause analyses to ensure appropriate CAPA resolution.

  • Participate in internal and external quality review activities.

Quantitative Dimensions:

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

Organizational Context:

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

Qualifications:

Required

Education

  • Bachelor's Degree

Experience

  • Minimum 4 years in the drug development setting with a minimum of 2 years in a non-medical technical writing with demonstrated expertise in related competencies, including AP-style guidance, version control, and general document control process requirements in the pharmaceutical industry.

  • Two years experience in process mapping and/or process improvement methodologies.

  • Understanding of the global drug development processes, quality management principles and standard operating procedures.

  • Working knowledge of ICH/GCP regulations.

  • Excellent oral and written communication and presentation skills, in English, with an ability to interact at all levels of personnel in a global environment.

  • 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.

Preferred

  • Advanced degree, MS or PhD or equivalent

  • Location for this position is Northbrook, IL

  • Experience with continuous process improvement activities

  • Working knowledge of GMP and GLP regulations

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Category Medical & Development

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

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