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Astellas Pharma Associate Director, 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 an Associate Director, Quality & Process Operations Strategy opportunity 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 Associate Quality & Process Operations Strategy Director, this position will be responsible for leading cross-functional quality and process operational initiatives through collaboration with cross-functional stakeholders.

This position is responsible for leading quality and process improvement projects within M&D by understanding business processes along with system implications and proactively driving GCP compliance through collaboration with cross-functional subject matter experts to address gaps and/or new growth opportunities in the business.

Essential Job Responsibilities:

  • Lead continuous improvement projects to sustain the Global Quality Document Maintenance Model driving operational excellence, continuous improvement, sustainability and consistent application of QD standards.
  • Lead cross-functional stakeholders through the development and implementation of improved Quality documents to support consistent application of GCP regulations.
  • Collaborate with Development stakeholders, and other M&D stakeholders as relevant, on GCP related activities and issues and act as GCP expert/consultant.
  • Partner with subject matter experts to identify, share and incorporate best practices into future iterations of quality document processes, tools, training and/or guidance.
  • Partner with Clinical Research and Quality Assurance (CRQA) to identify areas of business risk and work collaboratively to prioritize high risks and develop mitigation strategies to reduce the risk.
  • Provide Quality management support to the business to ensure consistent application of Quality by Design principles.
  • Analyze compliance trends and manage remediation of existing and emerging risks.
  • Collaborate with the business to complete Quality document gap analyses, writing and review of updated and/or improved Quality documents.
  • Support the business in performing effective root cause analyses to ensure appropriate CAPA resolution.
  • Monitor and evaluate CAPA effectiveness.

Quantitative Dimensions:

Responsible for evaluating opportunities to identify continuous improvement opportunities to increase compliance with internal SOPs and external GxP regulations. Responsible for providing GCP expertise to the business. Responsible for budget and timelines associated with assigned initiatives. May provide oversight and management of vendors or contractors working on a project, as applicable.

Organizational Context:

Reports to the Head of Quality & Process Operations Strategy. Collaborates with cross-functional peers and leaders and subject matter experts to drive quality and process initiatives forward. May have a speciality and expertise aligned to a subset of business processes within M&D as a major focus, for example Clinical Research Quality Assurance, Data Sciences, Clinical Sciences.

Qualifications:

Required:

  • Education: BA/BS
  • Minimum 10 years in the pharmaceutical industry and/or management consulting group focused on Quality and/or Process Management or clinical operations, with minimum 4 years in the drug development setting in a GCP role.

  • Strong understanding of the global drug development processes, quality management principles and standard operating procedures to ensure cross-functional alignment.

  • Proven track record of facilitating process optimization and process change initiatives in a cross-functional setting.
  • Assists with the development of the reporting, tracking, and analysis of quality initiatives and trend reporting of quality issues.
  • 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.
  • Experience in leveraging data to drive quality oversight.
  • Strong and effective problem solver with the ability to both recognize and anticipate problems.
  • Demonstrated ability to translate solutions into sustainable action plans at a global level that are effectively disseminated and implemented through stakeholder collaboration.
  • Demonstrated ability to effectively build business relationships and influence without authority as part of a matrix organization.
  • Demonstrated ability to prioritize multiple projects efficiently.
  • May require up to 10% international travel.

Preferred

  • Advanced degree, MS or PhD or equivalent
  • Experience with development of Quality Health dashboards

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Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled

Category Medical & Development

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