Completes audits to assess accuracy and quality of scientific data submitted to the regulatory agencies in support of new drug application, biological licensing agreement, animal drug application or medical devices application. Conducts and performs investigations and ensures conformance to regulations and company standard operating procedures. Documents audit observations and makes recommendations for corrective and preventive action. May create and maintain clinical quality assurance databases, reports, and files. Performs quality reviews and tracks corrective and preventive actions until closure. May act as an advisor on clinical quality assurance protocol, amendments and/or biological licensing agreements. May also audit operating systems, processes and procedures. May support risk management operations, including ongoing review of literature and compilation and interpretation of safety data to support product strategies. May plan and prepare report drafts for products, compliance statements, audit certifications, and safety issues for regulatory submission. May use six-sigma methodology. May provide training on GCP and current regulations for those undertaking clinical studies
The Senior Manager, IT Quality Assurance is responsible to help 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 management that the controls they have implemented are being executed.
The Senior Manager is responsible for providing guidance 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 Senior Manager is responsible for supporting quality awareness efforts to ensure quality principles are disseminated throughout the IT organization and affected user communities.
Quality Assurance Framework:
Responsible as assigned, to design and deploy Quality Assurance (QA) processes, procedures, and systems (including QMS) to assure compliance with applicable GxP regulations and company standards
Scope includes the following areas:
Collaborates within ITQA to create, update and maintain Computer System Validation (CSV) policies, standards, guideline, and procedures including templates for Installation Qualifications (IQ), Operating Qualifications (OQ), Production Qualifications (PQ) and IT regulation (e.g. 21 CFR Part 11, Data Integrity) compliance as assigned.
Collaborates with project teams to create, update and maintain SDLC (Software Development Life Cycle) standards, guidelines, and procedures used for GxP systems.
Creates and updates corrective and preventative action (CAPA) processes, procedures and systems for GxP Systems as assigned.
Creates and updates deviation management processes (including investigations and root cause analysis) and procedures for GxP systems as assigned.
Creates and updates change control management processes and procedures for GxP systems as assigned.
IT System Implementation and Maintenance:
Responsible as assigned for validation strategies and validation planning for new, modified or retired GxP IT systems.
Reviews and approves documentation of SOPS, SDLC tasks, and other ITQA processes for use in supporting compliance with GxP regulations and guidance.
Manages and maintains a repository of controlled documents related to GxP ITQA Systems.
Internal and External Auditing and Compliance Management:
Responsible as assigned for GxP auditing for internal and external computing platforms and solutions.
Conducts audits and periodic review as assigned for quality assurance compliance with regulations and Eisai IT policies and standards for internally deployed IT systems.
Conducts external audits and periodic reviews as assigned 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 and QA groups as assigned 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.
Engagement with Regulatory Agencies:
Collaborates with management to engage with regulatory agencies as assigned on GxP related IT topics.
Interfaces with Regulatory agencies as assigned to represent Eisai to authorities and regulatory persons.
Collaborates to monitor IT regulations issued by each country where Eisai business operates and updates corporate IT policies, guidelines, etc to assure compliance.
Training and Education:
Responsible as assigned for providing direction and guidance for GxP training and education of the Eisai workforce.
Provides mentoring to teams and individuals to ensure compliance with regulations and Eisai policies and standards for employees, contractors and managed service providers for GxP related systems.
Communicates with and trains IT employees, contractors and managed service providers on quality awareness and compliance process improvements.
Minimum of 8 years related work experience with quality assurance and testing life cycle activities and deliverables.
Minimum of 3 years work experience with pharmaceutical regulatory compliance and global regulations for computerized systems validation
Knowledge & Experience
8+ years of relevant industry experience, including Computer System Validation in GxP environments.
2+ years in a leadership role in IT Quality Assurance. Must be able to lead a project to completion with limited direction.
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 that 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.
Bachelors degree in the field of computer science, information science, management information systems, or business administration
Eisai requires all new hires to be fully vaccinated against COVID-19 and provide valid proof of vaccination as of their start date, to the extent permitted under applicable law. This requirement is a condition of employment at Eisai, and it applies regardless of whether the position is located at an Eisai site, field based or is fully remote. If you are unable to receive the vaccine for qualifying medical reasons (including pregnancy-related), or religious reasons (sincerely held religious beliefs), you will have an opportunity to request a reasonable accommodation