Senior Director, Clinical Quality Assurance

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 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

• Bachelor's or Master's degree with 15 or more years significant clinical pharmaceutical experience (i.e., 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 area, operational management of quality processes through cross-functional teams, as well as budget planning & 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 role, including strategic oversight and strategic stakeholder management across levels, internally and externally.
• Position requires travel. Travel up to 20%.
• Mostly remote, required to be onsite at Nutley, NJ once per week

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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 & Eisai Inc. Long Term 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 .

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.

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