Hybrid Senior Director, Clinical Quality Assurance

at Cision

• Job title: Senior Director, Clinical Quality Assurance
• Job type: Full Time
• Experience level: Senior
• Salary: $236,900 - $310,900 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Nutley, United States

About the role

• Lead global Clinical Quality Assurance strategy, audits, inspections, and digital transformation for Eisai pharmaceuticals. Oversee teams, vendors, budgets, and regulatory interactions.

Responsibilities

• Direct and drive 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)
• 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
• Champion CQA’s mission of ‘Quality as enabler of business’ and lead global continuous improvement initiatives
• Trend and leverage internal audit and industry intelligence and share results to improve 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
• Anticipate risks to quality support and implement pre-emptive actions through cross-functional engagement
• Lead future-focused skill-development initiatives through cross-functional/external partnerships
• Align clinical portfolio, business strategy, clinical studies, and related functions (data management, clinical operations)
• Build and manage relationships with key stakeholders and regulatory bodies
• Explore, identify, evaluate, and leverage advanced analytics, technology, and best practices within clinical quality
• Present and publish at conferences/journals on clinical quality topics
• Manage and retain talent 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
• 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 and operational management of quality processes
• Budget planning & management experience
• 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 stakeholder management across levels
• Position requires travel up to 20%
• Line management experience for teams of ~4-10 CQA staff members
• Candidates near Eisai’s NJ/PA locations will be preferred

Benefits

• Eisai Inc. Annual Incentive Plan
• Eisai Inc. Long Term Incentive Plan
• Employees are eligible to participate in Company employee benefit programs (see https://us.eisai.com/careers-at-eisai/benefits)
• Certain other benefits may be available for this position, please discuss any questions with your recruiter
• Remote Work Arrangement for candidates near NJ/PA locations: 2-4 days in office (Nutley/Exton) per month and 1-2 audits quarterly; CQA expected to be present in Nutley for inspections or critical inspection mgmt. activities