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Astellas Pharma Sr. Manager/Associate Director, Quality Technology Planning & Strategy 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 & Scope:

Responsible for supporting to Group lead of QT Planning & Strategy Group in Quality Technology and the operational excellence in Pharmaceutical Development Quality Management 1 & 2 Groups including CTM and commercial readiness activities. Responsible for contributing to the strategic partnerships and collaboration with senior managements in QA organization, RX+ Accelerator, Pharmaceutical technology and M&D managements, and to contribute to good management of global function in Quality Technology in the related local site. Support to Group lead in Quality Technology finctions to contribute to develop and maintain comprehensive Global Quality Management System under development stage such as Clinical Trial Materials and product commercialization phases until first product launch. Responsible for contributing to establish and improve a comprehensive quality system for manufacturing, global supply/distribution of CTMs/GMP batches and prototype of medical device under development and commercialization phase that comply with applicable GMP, GDP, Medical device QMS and other regulatory requirements. Collaborate with internal and external key stakeholders to contribute to development and alignment of processes, operating procedures, systems and/or programs that related to the compliance with the relevant regulations such as GMP/GDP and/or medical device QMS in the program/projects for Astellas new commercial products and clinical trial materials with global regulatory requirements and to support business expansion of commercial products, according to the guidance and/or instruction by Group Leads in Quality Technology. Responsible for contributing to RX+ business and establishment/improvement of QMSs for RX+ business/products.

Reports to the Group Lead of QT Planning & Strategy Group in Quality Technology and contributes to the development, implementation, and successful execution of the QA mission, objectives and 3-5 year strategic plan.

The purpose of this role is to lead Quality Technology oversight activities for development product QA including CTM and new product commercialization including product launch of new Astellas Commercial Products which are including RX area, ATMP, medical device and Business to Business type of products/services. This position is responsible for the optimal development, allocation and management of the Group Quality staffs, processes, systems and resources in the applied site (Leiden, Northbrook or Japanese sites). The position will have the responsibility for leading QT oversight for the QMSs on Clinical Trial Material (CTM) products. This position will have the responsibility to support Due Diligence activities for New Business Evaluation Program managed by Business Developent and RX+ Accelerator, under development stage. The incumbent will be responsible for supporting as the QA role for preparation for product launch of new Astellas Commercial Products for RX+ business.

In addition to above, the incumbent will be responsible for supporting engineering QA activities in Astellas manufacturing sites from GMP perspectives such as commissioning & qualification for the GMP facilities.

The scope of this position will be responsible for leading of oversight activity for the quality assurance activities related to CTM and commercial readiness activities which are defined types of projects taken by Pharmaceutical Development Quality Management 1 & 2 Groups, and will be responsible for leading of the QMS enhancement activity and the quality assurance activities of RX+ business projects.

Essential Job Responsibilities:

  1. Develop, execute and implement the strategy of achievement for QA mission, vision and strategic objectives and execute operational plans which align to the QA vision. Accountable for their successful execution and achievement of annual and mid term strategic goals.

  2. Contribute to manage the QT(Quality Technology) members as the site team lead/manager, and support Group Lead of QT Planning & Strategy Group.

  3. Support and consult any technical QA issues to relevant stakeholders, in order to comply with the relevant regulations. The Site Team Lead contributes to the appropriate execution of QA Activities by either proposal to Global Head of QA, Quality Technology Head, Group Lead of Pharmaceutical Development Quality Management 1 & 2 Groups, or actual role for the key functions under the supervision of Group Lead of QT Planning & Strategy Group.

  4. Lead and execute key activities in QT Planning & Strategy Group as follows;

  • Oversight and support the activities in QT taken by Pharmaceutical Development Quality Management 1 & 2 Groups to ensure appropriate level of contribution to any types of development projects and execution of overall quality assurance activities under development to commercialization stages

  • Execute and manage QA activities for RX+ business including medical device and B to C (Business to Consumer) business products/services

  • Act as Quality Engineer or as the equivalent roles for medical device

  • Act as the secretariat role for Risk Evaluation Committee (REC) for CTM

  • Preparation and coordination of specific technical QA guideline/SOP and/or policy documents under development and commercialization stages for RX+ business

  • Act as the secretariat role for global Meetings in Quality Technology (QT meeting, QT-LT meeting, etc.)

  • Coordination and execution of the QT management review

  • Supporting and consultation to assess GMP facility design to be built for Global GMP/GDP compliance perspective

  • Global coordination and support of Annual CTM supplier audit planning and execution

  • Execution of the DD (Due Diligence) activities for evaluation of business partners and new products

  • Management of QA Agreement prepared by Project Basis

  • Collecting any relevant information on the new areas, from academia, relevant industry

  1. Support to develop and maintain effective working relationships with internal and external stakeholder functions, including external partner quality organizations. Support local site team members of the QT and foster an environment of collaboration, trust, quality, innovation, and continuous improvement within the departments and between Quality Assurance and other functional departments.

  2. Responsible for the effective implementation of optimal organizational structure(s) which maximizes the use of resources globally and reflects business needs and conditions. Creates an environment that enables each team member to optimally operate in the matrix environment of QA and Astellas.

  3. Manages and grows the team through effective recruitment, performance management, development planning and retention. Delegates responsibilities and empowers team members to achieve the goals of QT Planning & Strategy Group in QT. Provides optimal oversight and supervision while developing individuals and leveraging their skills and abilities to ensure goals are achieved.

Quantitative Dimensions:

Responsible for contribution to obtain the following quality outputs and deliverables in QA organization for QT Planning & Strategy Group. Provides operational leadership in driving consistent compliance in QT Planning & Strategy Group related to QA responsibilities, under collaboration with other regional/local site managers and group leads in Quality Technology.

  • Responsible for oversight of QMS for CTM and commercial readiness (Approximately 50+ batches/year or more).

  • Responsible for Business Partner collaboration for joint development programs.

  • Coordinates, maintains and administers all Quality Agreements and QA oversight for activities conducted by Pharmaceutical Development Quality Management 1 & 2 Groups.

  • Coordinates, maintains and administers QA oversight for RX+ Business QMS in Astellas (Approximately 20+ active projects).

  • Support and consultation for inspection readiness and facilitation of regulatory agency inspections for both internal plants and external CMOs regarding CTM under development stage.

  • Pre-Approval Inspection readiness and support of regulatory agency inspections at both internal Astellas Plants and CMOs to support commercial readiness activities of new Astellas Commercial Products.

Organizational Context:

The position, reporting to the Group Lead of QT Planning & Strategy Group. This person will be responsible for the QA activities related to CTM, Commercial Readiness, QT oversight, Engineering/Qualification/Validation support for GMP sites and RX+ business/QMS under development stage and commercial readiness.

  • Has approximately 2-3 or more direct reports leading functions of QT Planning & Strategy Group.

  • Works directly with group leads of QT Planning & Strategy Group.

  • Leads the local team in QT Planning & Strategy Group of approximately 2-3 or more staffs in the local site in EMEA, AMR and JAO region.

  • Collaborates with the senior managements in QA, Medical & Development, Business Development, Pharmaceutical Technology, DDR, RX+ Accelerator and so on, to achieve job responsibilities

Qualifications:

Required

  • BA / BS in a science or engineering related field, with 8+ years of pharmaceutical or medical device or consumer business industry experiences (in medical device, biologic, solid dose and/or parenteral manufacturing) related to QMS, CMC, GMP, GDP, GLP, GCP, Validation, QC and/or QA.

  • Preferred 5+ years of QA in pharmaceutical science or medical device or consumer business experiences and managerial experience in 1+ years.

  • In-depth knowledge of GMPs/QMS and other relevant regulations, as required, with a broad knowledge of quality principles and industry trends.

  • Effective written and oral communication and interpersonal skills, facilitation, and influencing skills with an ability to effectively work across the Astellas groups and with external stakeholders.

  • Ability to represent the company to external stakeholders during vendor audits and interacting with regulatory agencies.

  • Ability to apply industry knowledge and interpretation to anticipate global impact of changes, issues and strategies necessary to facilitate open discussion. Ability to develop and maintain effective relationships with internal and external stakeholders including Global Astellas entities.

  • Ability to direct multiple areas of responsibility with limited oversight. Demonstrated experience in developing / executing quality strategies with a pragmatic approach to decision-making.

  • Role could be filled at a Sr. Manager level based upon candidate experience.

Preferred

  • In-depth know of global industry standards and regulatory requirements (e.g., US, EU and Japan).

  • Demonstrated experience in directing and coaching individuals and project teams.

  • Direct experience in Manufacturing or QMS Operations for RX, Medial Device or Consumer Business.

  • Direct experience in Manufacturing Validation support (e.g., Cleaning, Process, Equipment, Requalification, Computer).

  • Commercial experience for budget management and strategic planning

  • GMP/QMS auditing experience of Biologics, Solid Dose, Parenteral Manufacturing and / or medical devices.

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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