Supplier Quality Engineer leading Preventive Quality projects and ensuring compliance with AS9145 standards at Boeing. Collaborating with suppliers and internal teams to optimize product deliverables.
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
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