CMP Supplier Quality Engineer responsible for implementing supplier quality programs and collaborating with global teams at Micron. Ensuring compliance with Supplier Requirements Standards and overseeing quality performance metrics.
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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