Senior Director, Clinical Quality Assurance

Eisai Clinical Quality Assurance Professional

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care 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 Clinical Quality Assurance Professional (QAP) position is responsible for design, delivery and execution of the global Clinical Quality Assurance (CQA) strategy including audit and inspection management, issue management and oversight of the Quality Management System. This role is responsible for Good Clinical Practice (GCP) and for assuring the compliance of projects, products and programs with Eisai's Standard Operating Procedures (SOPs), Policies, and all applicable worldwide regulations and guidelines (e.g. EU Directives, US FDA, PMDA, ICH, and National regulations). In the current times, drug development is going through a significant transformation with digitalization, utilization of big data and predictive analytics to revamp innovation in medicine. Clinical Quality Assurance at Eisai is an independent organization driving end-to-end quality in the R and D organization. This role is responsible for leading the digital transformation to enhance current quality oversight capabilities and knowledge within CQA and Eisai. This is a high visibility position with great impact potential.

Essential Functions

• Direct and drive design, delivery, and execution of the global Clinical Quality Assurance (CQA) strategy for the country / region in scope (including audit and inspection management, issue management, and oversight of the quality management system).
• Conduct complex audits of sites, vendors and internal process.
• Train junior auditors and participate in training audits.
• Contribute to the overall global clinical quality strategy and roadmap, and drive execution as a part of that plan.
• Champion CQA's mission of 'Quality as enabler of business'; lead global initiatives for continuous improvement.
• Trend and leverage internal audit and industry intelligence relating to inspections and share results with teams to improve the effectiveness of the quality management system.
• Direct and oversee operational and budget management, vendor management, development & tracking of timelines, and assess long-term resource, technology, and skill needs for respective program(s) within clinical quality area.
• Anticipate immediate and long-term risks to quality support for overall operations continuity and propose / implement pre-emptive actions through engagement with cross-functional teams.
• Direct future-focused skill-development initiatives through cross-functional / external partnerships to equip and adapt the workforce to evolving technologies.
• Align clinical portfolio, business strategy, clinical studies, and related functions e.g. data management, clinical operations.
• Build and manage relationships with key stakeholders in the business area.
• Explore, identify, evaluate, and leverage opportunities for advanced analytics, technology / best practice adoption within clinical quality.
• Build relations with the industry-wide QA community, present, publish at conferences, journals on clinical quality topics.
• Build and manage overall relationships with regulatory bodies to address emerging needs and issues.
• Manage and retain talent within own area including goal setting, performance management, development, and engagement.
• Line management of team of 4-10 CQA staff members.

Requirements

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.