Sr. Manager, IT QA

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

• Collaborate with stakeholders, external vendors, and project teams for creation, assessment, update, and maintenance of policies, standards, and procedures(e.g., CSV, deviation management, change control management, CAPA).

• Conduct planning, implementation, and maintenance for validation strategies of assigned GxP systems(including review and approval of relevant documentation, maintenance of controlled document repository, etc.).

• Conduct internal/ external auditing and compliance management as assigned(e.g., GxP auditing of assigned computing platforms and supplier audits).

• Interface with regulatory agencies to represent Eisai as required and collaborate with management on GxP-related System topics.

• Monitor global regulations and related revisions to national and international policies and guidelines for compliance.

• Provide training, mentoring, and guidance around GxP & quality awareness to relevant internal teams, contractors, and managed service providers to enable compliance.

Requirements

• Bachelor's (8+ years' experience) or Master's (8+ years' experience) degree in Computer Science, Information Technology, Engineering, or a related field with 8+ years of relevant pharmaceutical industry experience, including Computer System Validation, SDLC, quality assurance, and testing life cycle activities and deliverables in GxP environments.

• 8+ years of experience with pharmaceutical regulatory compliance and global regulations for computerized systems validation.

• 2+ years of experience in a leadership role in systems quality assurance, leading projects through to completion with limited direction.

• Experience with the validation of computer systems performing regulated pharmaceutical operations for commercially marketed products.

• Experience in leading internal and external supplier-related supplier audits.

• Experience with GxP expectations, especially 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 lifecycle.

• Proven experience in test management; has an excellent understanding of the role of software testing and all testing events to support varied projects/ programs including in-house development, third-party managed applications, infrastructure projects, migration, and integration projects.

• Proven performance in earlier role.

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.

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