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Astellas Pharma Associate Quality Operations & Intelligence Manager 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 activities supporting the Astellas Quality Intelligence Program (AQuIP) by developing and maintaining tools and templates, and reporting Quality Intelligence (QI) information and completing daily updates to the AQuIP site. Provides support with Inspection readiness activities, which include measuring progress output and obtaining and maintaining information for management of Regulatory Agency Inspections.

Reports to the Associate Director Quality Operations & Intelligence, and contributes to the development, implementation, and successful execution of the QA mission, objectives and 3-5 year strategic plan.

The role supports and occasionally leads selected projects or activities (as listed below) to ensure that QA processes are effective and efficient, state-of-the-art, standardized, and transparent to functional customers.

Essential Job Responsibilities:

  • Performs daily monitoring of QI and management of the AQuIP SharePoint Site, which includes: monitoring various sources of QI; identifying QI applicable to Astellas, posting QI information to the AQuIP SharePoint site.

  • Performs routine maintenance on the AQuIP SharePoint Online site, which includes: creating new SharePoint pages; posting new or updated content; removing out of date content.

  • Provides logistical support for Regulatory Agency M&D Inspections, which includes: supporting inspection preparation training sessions with subject matter experts (SMEs); collection and collation of study related information from SMEs; supports inspections in the backroom with assigned tasks.

  • Performing routine internet searches for QI to support AQuIP and inspection preparation activities.

  • Supports the implementation of assigned QA strategies and process improvement projects, which contribute to QA compliance, efficiency, and effectiveness.

  • Assists in the management of QA-tools such as inspection notification distribution lists, AQuIP mailbox, and the Inspection Management mailbox to ensure consistency in QA activities.

  • Provides operational support for QA process and compliance improvement initiatives as assigned.

  • Supports the monthly reporting of QI data as part of management review, which includes: obtaining QI data on posting to AQuIP; completing management review slides; submitting information to management review.

  • Supports the process to assess QI for potential impact to the Astellas Quality Management System (QMS), which includes: communicating with SMEs, managing the list of ongoing document reviews; providing routine status updates.

Quantitative Dimensions:

  • Supports approximately 400 people in QA

  • Supports monthly and quarterly reporting of QA activities globally

  • Responsible to monitor QI from approximately seven sources for approximately 225 AQuIP updates per month.

  • Supports 3-5 Quality Operations activities

  • Responsible for logistic support of 2-4 GxP Regulatory Agency Inspections per annum

Compliance:

  • Embed Compliance Culture across all regions of the business ensuring Integrity in Action is actively applied in all initiatives.

  • Ensure Quality Assurance function(s) strictly adopt a culture of ethics and compliance; leading by example and appropriately challenging non-compliance.

  • Ensure adherence to Astellas policies relating to Ethics and Compliance standards and interactions with Healthcare Professionals (HCPs), Healthcare Organizations (HCOs) and Patient Organizations (POs).

Mandatory Compliance Requirements:

  • To be aware of Astellas' Group Code of Conduct and associated policies and procedures and other applicable laws, codes and regulations.

  • Clarify and seek guidance as required, and raise any concerns, in a timely manner, with relevant manager; which may include reference to the Ethics and Compliance Team and/or Ethics and Compliance Helpdesk.

  • Undertake and comply with relevant mandatory Ethics and Compliance training and updates to maintain personal awareness; all training to be undertaken in a timely manner.

  • Be aware of and comply with, the Astellas Way and Astellas Competencies, in terms of expected values and behaviors, in addition to Astellas' HR policies, procedures and guidelines

Organizational Context:

  • Reports to the Associate Director, Quality Operations & Intelligence

  • Peers include QA managers and Associate Directors in Clinical QA, Data Integrity/Technology & Data QA, Quality Governance (Management Review), Quality Process & Controls and Device Quality and Quality Operations.

Qualifications:

Required

  • Bachelor's degree/University Degree required (Life Science preferred); Advanced degree preferred.

  • Minimum 3 years of experience in pharmaceutical, biotechnology, or related industry.

  • Minimum of 2 years' experience in a Quality organization and/or minimum of 2 years project management experience, preferably in a highly matrixed, multicultural global setting, requiring facilitation, negotiation, problem-solving, and conflict resolution skills.

  • Understanding of GxP regulations for both marketed and investigational products, and excellent knowledge of global health authorities

  • Proficiency in Microsoft Office, Access, and Project.

  • Affinity with IT systems

Skills and competencies:

  • Strong interpersonal skills and multi-cultural /intercultural awareness; able to solicit for input, negotiate and build consensus for plans and priorities and able to develop effective relationships through collaboration. Forges strong working relationships with all colleagues and stakeholders.

  • Excellent oral and written communication and presentation skills in English.

  • Strong planning and organizational skills and experience in managing multiple priorities simultaneously.

  • Ability to proactively predict and resolve complex problems, think strategically and tactically, generate solutions to complex problems and build consensus across the global organization. Able to generate insights and leverage learnings at the individual, team, and functional level.

  • Domestic and international travel at 5% is required.

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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