Astellas Pharma Associate Director IT-QA 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, IT-QA opportunity in Northbrook, IL.
Purpose & Scope:
This position will serve as the global main point of contact within QA and between QA and other divisions (CRQA, PTech and IS) acting as business process owner for TrackWise® Quality Management System e-platform. The role will manage all activities in relation to the business process owner responsibilities including creation of annual plan to introduce/improve the system, system routine update and maintenance, issue management, oversight, evaluation and approval of all changes (including performing risk assessments).
This position is responsible for supporting various IT system projects and ensuring these are performed in accordance with regulatory requirements (EU GMP Annex 11 & 21CFR part 11) and internal Astellas SDLC (Software Design Lifecycle approach) & Computer Systems Validation (CSV) procedures. The role holder will also support various global projects which have an IT system component to it e.g. New QMS Platform, Digital Transformation etc.
The AD IT-QA oversees and defines quality expectations and provides support to the necessary functions and contracted third parties (where applicable) to ensure effective implementation through robust quality systems that meet GMP. Anticipates and prioritizes QA activities based on risk. This person will act as a Quality Ambassador focusing and influencing Astellas functions and third parties to comply with Astellas quality standards, policies and industry GMP requirements.
In addition to the IT duties, the role will also support Data Integrity and Regulatory Intelligence governance activities applicable to GMP/GDP globally. Support the management of RI program in order to ensure Astellas GMP/GDP compliance to new and revised regulations and improve Astellas Quality System. Monitors and closes gaps identified within RI program. Serves as a Data Integrity Officer for GMP/GDP areas. Provides management support to develop and manage the Data Governance Program. Contributes to the development, implementation, and successful execution of the QA mission, objectives and long-term strategic plan. Serves in a Quality Systems leadership role as part of QA.
Essential Job Responsibilities:
Non-Medical Final Signatory: This role is a Non-Medical Final Signatory. The incumbent is required, subject to qualifying training, to sign the separate document entitled "APEL Key Accountabilities" for Non-Medical Final Signatory. It outlines detailed responsibilities for a Non-Medical Final Signatory.
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 Competences, in terms of expected values and behaviors, in addition to Astellas' HR policies, procedures and guidelines.
Maintenance and Continuous Improvement of TrackWise® and other IT systems
- Create the annual plan for introducing/ improving IT systems (IS portfolio) through collection of QA and CRQA demands.
- Clarify user requirements so that IT vendor can understand configurations to change, estimate cost.
- Support IT System Projects in terms of SDLC/CSV including both global and local projects(systems)
- Serve as TrackWise® business process owner
- General update and maintenance in BAU operation
- Promote new e-QMS introduction
Assessment of the effectiveness/compliance of the Quality System in Supply Chain and 3PLs
- Employs a Risk Management approach to evaluate Quality issues.
- Proactively identifies and communicates major compliance issues to Management. Prepares formal corrective/preventive action plans using a Risk based approach. Demonstrates prudent independent judgment to balance quality expectations and other stakeholder needs.
- Take part in special audit, as required.
Surveillance of Significant Quality Issues (SQIs) and resultant investigations in the EMEA Region.
- Assures compliance with Astellas corporate policies, Global Procedures and Guidelines, as well as regulatory agency standards.
- Conducts and coordinates QA assessments of SDLC/CSV as assigned. Maintains related records and tracking systems.
- Provides leadership to achieve quality goals, while developing measures to monitor the effectiveness of the IT-QA function itself and drive remediation for improvement
- Leads and/or participates in global, departmental and cross-functional working teams to address IT-QA compliance issues and provide leadership regarding quality, compliance and Astellas QA department requirements. Drives Continuous Improvement. Develops and maintains effective relationships with internal and external stakeholders, which may include regional and global Astellas entities.
- CSV documentation support in a project, Create/Update CSV documents like Project Validation Plan, User Requirement, Design Configuration Specification, Test Scripts, and Validation Summary Report for new IT system development or BAU (Business-As-Usual) change.
- Authors, revises, and performs maintenance and administration of IS controlled documents (i.e., SOPs, WPDs, Forms, etc.) as necessary.
- Monitoring and periodical review of IT-QA activities and participation in Management Review.
- Participate as auditor in inspections, as required.
- Prepare the QS monthly report to QA.
- Other such duties as may be reasonably required by the business.
- Applies knowledge of global GMP & GDP requirements including robust and demonstrable understanding EU Directives, EU GMP & GDP regulations, ICH Guidelines and other applicable regulations policies and procedures for the oversight and management of QMS requirements
- Proactive monitoring of key information sources for GMP and GDP Regulatory Intelligence in a timely manner, leading to generation and distribution of a quarterly GMDP regulatory Intelligence report.
- Oversight and execution of the QA Regulatory Intelligence Management process including; initiation of assessment process on identification of a relevant trigger, performing preliminary assessment, liaising with Quality Leads, Process owners and other SMEs to facilitate a continually compliant global QA Quality System, monitoring for rapid alerts and noncompliance reports.
- Manage Regulatory Intelligence TrackWise® workflow and SharePoint site.
- Analysis of publicly available Regulatory Inspection findings, to identify trends for Astellas sites to be informed of, and inform Astellas sites, e.g. EMA rapid alerts, FDA warning letters.
- Provide status overview and metrics related to the QA Regulatory Intelligence Management process.
- Act as an additional point of contact globally for QA Regulatory Intelligence queries from the rest of the business.
- Advocacy and provision of Astellas input into GMP and GDP industry topics.
- Work collaboratively with colleagues and interested parties in all three regions in relation to data integrity activities, in order to progress Data Integrity compliance and the information Governance agenda.
- Identify and perform training in Data Governance/data Integrity topics.
- Provide expert, professional and pragmatic guidance and assistance in regard to the identification, implementation and maintenance of Data Integrity across the QA network both in terms of the use of computerized systems and paper documents and records. Maintain current knowledge of Data Integrity, in particular how Health Authorities are inspecting against this topic, and any observations thereof, and industry trends.
- Provide and maintain supporting tools, processes, and procedures associated with data Governance and Data integrity to manage the associated documentation/records.
- Monitoring and periodical review of Quality Systems associated with the maintenance of Data Integrity and participation in Management Review activities and Data Integrity audits as appropriate.
The role holder will perform a global role and have responsibility for business process owner activities for TrackWise® and for monitoring global regulatory intelligence.
- Influences Directors and Managers in other functions (e.g. M&D, Manufacturing Plants, IS etc.). No budgetary responsibilities, however, activities are carried out in a cost-conscious manner.
There are no head count responsibilities assigned to this role.
Employees at all levels globally
Manufacturing Plants QA
IS, CRQA and PTech members
External suppliers and consultants e.g. TCS, Accenture, IBM etc.
Pharma sector experience with strong customer focus; in multi-disciplinary, matrix and cross-cultural settings.
Track-record of leading planning process with excellent organizational and collaboration skills
Proven compliance expertise; to understand and comply with industry laws and relevant regulations.
Coaching and collaboration skills to interact with all levels of personnel to achieve shared goals.
Demonstrable examples of ability to develop, coach and enable high performance teams and proactively promote best practice and knowledge sharing.
Proven ability to influence, (appropriately) challenge and engage diverse senior stakeholders.
Fluent in written and verbal business English
In depth knowledge of GMP, GDP and other regions as required with a broad knowledge of quality principles and industry trends.
Ability to apply industry knowledge and interpretation to anticipate global impact and contribute ideas for strategies and levels of management. Ability to develop and maintain effective relationships with internal and external stakeholders including Global Astellas entities.
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
Category Quality Assurance/Quality Control