At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai’s human health care (hhc) mission. We’re a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer’s disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you.
The Sr Mgr, GxP Systems 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 a GxP Systems 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.
Essential Functions
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 GxP Systems Quality Assurance 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 GxP Systems Quality Assurance processes for use in supporting compliance with GxP regulations and guidance.
- Manages and maintains a repository of controlled documents related to GxP Systems Quality Assurance.
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.
Requirements
- 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 GxP Systems 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
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Eisai Salary Transparency Language:
The base salary range for the Sr. Manager, IT QA is from :129,800-170,400Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan.Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills.
Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit https://us.eisai.com/careers-at-eisai/benefits.
Certain other benefits may be available for this position, please discuss any questions with your recruiter.
Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.
Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:
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What We Do
At Eisai Inc., human health care (hhc) is our goal. We give our first thought to patients and their families, and helping to increase the benefits health care provides. As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., we have a passionate commitment to patient care that is the driving force behind our efforts to discover and develop innovative therapies to help address unmet medical needs.
Eisai is a fully integrated pharmaceutical business that operates in two global business groups: oncology and neurology (dementia-related diseases and neurodegenerative diseases). Each group functions as an end-to-end global business with discovery, development, and marketing capabilities. Our U.S. headquarters, commercial and clinical development organizations are located in New Jersey; our discovery labs are in Massachusetts and Pennsylvania; and our global demand chain organization resides in Maryland and North Carolina. To learn more about Eisai Inc., please visit us at www.eisai.com/US.
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