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Astellas Pharma Associate Quality & Process Operations Strategy Director 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:

  • Quality & Process Operations Strategy is a leader in aligning functions across M&D organizations in areas which impact quality and process management. 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. The position is responsible for 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 Quality Assurance (QA) 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 process document gap analyses, writing and review of updated and/or improved process 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 specialty and expertise aligned to a subset of business processes within M&D as a major focus, for example Quality Assurance, Data Sciences and Clinical Sciences.

Qualifications:

Required

  • Bachelor's Degree

  • Minimum 10 years in the pharmaceutical industry (e.g. Clinical Operations, Regulatory Affairs, Pharmacovigilance, Quality Assurance) focused on Quality Management and/or Process Improvement.

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

  • Proven track record of facilitating process optimization and process change initiatives in a crossfunctional 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.

  • Proficient in Microsoft Office (e.g. Word, Excel, PowerPoint, Visio, SharePoint)

  • May require up to 10% international travel.

Preferred:

  • Advanced degree, MS or PhD or equivalent

  • Working knowledge of GMP requirements

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 Medical & Development

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

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