Eisai
Overview
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 expanding in neurology and oncology, with a strong emphasis on research and development. We are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. 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 ensures compliance with Good Clinical Practice (GCP) and 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 undergoing digital transformation with digitalization, big data, and predictive analytics. Clinical Quality Assurance at Eisai is an independent organization driving end-to-end quality in R&D. This role is responsible for leading the digital transformation to enhance quality oversight 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 processes. Train junior auditors and participate in training audits. Contribute to the overall global clinical quality strategy and roadmap, and drive execution as 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 and tracking of timelines, and assess long-term resource, technology, and skill needs for respective program(s). Anticipate risks to quality and propose/pre-emptive actions through engagement with cross-functional teams. Direct future-focused skill-development initiatives through cross-functional/external partnerships to equip 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 and technology/best-practice adoption within clinical quality. Build relationships with the industry-wide QA community; present and publish on clinical quality topics. Build and manage relationships with regulatory bodies to address emerging needs and issues. Manage and retain talent within the area including goal setting, performance management, development, and engagement. Line management of a team of 4–10 CQA staff members. Requirements
Bachelor’s or Master’s degree with 15 or more years of significant clinical pharmaceutical experience (clinical development or operations, regulatory compliance). Substantial experience in Clinical Quality/CQA conducting a broad range of audits. Experience with GxP systems including general knowledge of CSV and associated regulations. Proven experience in strategy development within the area, operational management of quality processes through cross-functional teams, and budget planning and management. Significant project management experience leading multiple critical complex clinical quality projects and programs. Proven experience leading teams in a leadership capacity, preferred. Significant experience working in multifunctional environments and influencing senior stakeholders using data. Strong performance in earlier roles, including strategic oversight and stakeholder management internally and externally. Position requires travel, up to 20%. Mostly remote, onsite at Nutley, NJ once per week. Eisai Salary Transparency Language: The base salary range for the Senior Director, Clinical Quality Assurance is from 236,900-310,900. Under current guidelines, this position is eligible to participate in Eisai Inc. Annual Incentive Plan and Eisai Inc. Long Term Incentive Plan. Final pay determinations depend on experience, education, knowledge, and skills. Employees are eligible to participate in company employee benefit programs. For additional information on benefits, contact your recruiter. Eisai is an equal opportunity employer and prohibits discrimination in hiring and employment on race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Eisai participates in E-Verify.
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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 expanding in neurology and oncology, with a strong emphasis on research and development. We are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. 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 ensures compliance with Good Clinical Practice (GCP) and 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 undergoing digital transformation with digitalization, big data, and predictive analytics. Clinical Quality Assurance at Eisai is an independent organization driving end-to-end quality in R&D. This role is responsible for leading the digital transformation to enhance quality oversight 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 processes. Train junior auditors and participate in training audits. Contribute to the overall global clinical quality strategy and roadmap, and drive execution as 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 and tracking of timelines, and assess long-term resource, technology, and skill needs for respective program(s). Anticipate risks to quality and propose/pre-emptive actions through engagement with cross-functional teams. Direct future-focused skill-development initiatives through cross-functional/external partnerships to equip 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 and technology/best-practice adoption within clinical quality. Build relationships with the industry-wide QA community; present and publish on clinical quality topics. Build and manage relationships with regulatory bodies to address emerging needs and issues. Manage and retain talent within the area including goal setting, performance management, development, and engagement. Line management of a team of 4–10 CQA staff members. Requirements
Bachelor’s or Master’s degree with 15 or more years of significant clinical pharmaceutical experience (clinical development or operations, regulatory compliance). Substantial experience in Clinical Quality/CQA conducting a broad range of audits. Experience with GxP systems including general knowledge of CSV and associated regulations. Proven experience in strategy development within the area, operational management of quality processes through cross-functional teams, and budget planning and management. Significant project management experience leading multiple critical complex clinical quality projects and programs. Proven experience leading teams in a leadership capacity, preferred. Significant experience working in multifunctional environments and influencing senior stakeholders using data. Strong performance in earlier roles, including strategic oversight and stakeholder management internally and externally. Position requires travel, up to 20%. Mostly remote, onsite at Nutley, NJ once per week. Eisai Salary Transparency Language: The base salary range for the Senior Director, Clinical Quality Assurance is from 236,900-310,900. Under current guidelines, this position is eligible to participate in Eisai Inc. Annual Incentive Plan and Eisai Inc. Long Term Incentive Plan. Final pay determinations depend on experience, education, knowledge, and skills. Employees are eligible to participate in company employee benefit programs. For additional information on benefits, contact your recruiter. Eisai is an equal opportunity employer and prohibits discrimination in hiring and employment on race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Eisai participates in E-Verify.
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