Job DescriptionThe Director, IT Quality Assurance is accountable to ensure Eisai is choosing, deploying and supporting computing platforms and solutions in compliance with applicable global regulations and in accordance with Eisai standards and senior management intentions. Through an IT Quality Assurance framework, the role is to provide assurance to Eisai senior management that the controls they have implemented are being executed and are effective.The Director is responsible for providing direction on pharmaceutical regulatory compliance to Eisai, specifically the IT organization and IT user communities. He / She provides guidance and leadership on GxP and validation process improvements to increase efficiency and effectiveness and reduce cycle times and documentation overhead while maintaining the intended level of controls. The Director is responsible for implementing quality awareness to ensure quality principles are disseminated throughout the IT organization and affected user communities.Responsibilities include but are not limited to:1. Quality Assurance Framework: Accountable to design and deploy Quality Assurance (QA) processes, procedures, and systems (including a QMS) to assure compliance with applicable GxP regulations and company standards Scope includes the following areas:Collaborates with IT to create, update and maintain Computer System Validation (CSV) policies, standards, guideline, and procedures including Installation Qualifications (IQ), Operating Qualifications (OQ), Production Qualifications (PQ) and IT regulation (e.g. 21 CFR Part 11, Data Integrity) compliance.Collaborates with IT to create, update and maintain SDLC (Software Development Life Cycle) standards, guidelines, and procedures used to deploy GxP systems.Creates and updates corrective and preventative action (CAPA) processes, procedures and systems for GxP IT Systems.Creates and updates deviation management processes (including investigations and root cause analysis) and procedures for GxP IT systems.Create and updates change control management processes and procedures for GxP IT systems2. IT System Implementation and Maintenance: Accountable for validation strategies and validation plans for new, modified or retired GxP IT systems.Reviews and approves documentation of SOPS, SDLC tasks, and other IT processes for use in supporting compliance with GxP regulations and guidance.Manages and maintains a repository of controlled documents related to GxP IT Systems.Approves change control processes, procedures, and systems for GxP IT systems.3. Internal And External Auditing and Compliance Management: Accountable for GxP auditing for internal and external computing platforms and solutions.Conducts audits and periodic reviews for quality assurance compliance with regulations and Eisai IT policies and standards for internally deployed IT systems.Conducts external audits and periodic reviews for GxP quality assurance compliance with regulations and Eisai IT policies for GxP cloud-based solutions, hosted systems and external suppliers.Collaborates with IT Security to conduct external audits and periodic reviews for compliance with information governance and cyber security regulations and Eisai policies for GxP cloud-based solutions, hosted systems and external suppliers and partners.Monitors, measures, and reports metrics on Eisai performance and compliance with GxP related IT process and procedure controls.4. Engagement with Regulatory Agencies: Primary liaison to engage with regulatory agencies on GxP related IT topics.Interface with Regulatory agencies as required representing Eisai to authorities and regulatory persons.Monitors IT regulations issued by each country where Eisai business operates and updates corporate IT policies, guidelines, etc. to assure compliance.5. Training and Education: Accountable for providing direction and guidance for GxP training and education of the EJob Requirements:Minimum level of education and years of relevantBachelor degree in the field of computer science, information science, management information systems, or business administrationMinimum of 7 years related work experience with quality assurance and testing life cycle activities and deliverables.Minimum of 10 years work experience with pharmaceutical regulatory compliance and global regulations for computerized systems validation10+ years of relevant industry experience, including 5+ years in a leadership role in IT Quality Assurance with related experience such as Computer System Validation in FDA regulated and GxP environments.Experience with the validation of computer systems performing regulated pharmaceutical operations from drug development through manufacturing and post-market surveillance.Knowledge of Good Clinical Practices (GCPs), Good Manufacturing Practices (GMP); FDA regulations (21 CFR Part 11; Part 210; Part 211), EU GMP Annex 11: Computerized Systems, GAMP and Computer Systems Validation Life Cycle.Experience in managing application / system changes in accordance with GxP regulations.Proven experience in test management; has an excellent understanding of the role of software testing and of all testing events to support varied projects / programs including in-house development, third party applications, infrastructure projects, migration and integration projects.Strong problem solving ability through insightful solutions which address complex issues. Ability to dissect root cause of issues creating the best solution for Eisai considering quality, cost, and speed requirements.Strong understanding of project management principles and Systems Development Life Cycle processes.
Associated topics: performance test, process, prevention, quality, quality assurance engineer, quality assurance lead, software quality assurance, test, test engineer, tester
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
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