Client: A leading pharmaceutical company
Job Title: Manager of Quality Assurance
Duration: 6+ Months contract
The Manager Quality Assurance will play a key leadership role in the documentation, implementation, and on-going support of Sumitomo Dainippon Pharma Oncology’s GxP Quality systems, and associated processes and procedures. Particular emphasis will be on implementation of quality processes and systems in regards to outsourced services provided by CMOs, in support of the Clinical product manufacturing, testing, labeling and disposition for the Company’s oncology therapy products.
• Assists in the development, implementation, and management of quality management systems appropriate for the activities of contract manufacturing organizations (CMO) involved in the manufacture and test of the Company’s oncology therapy products, and ensures CMO adherence to GMP compliance and the Company’s quality expectations.
• Reviews and approves controlled documents as required, including protocols, reports, document changes, master batch records etc.
• Responsible for compliant, thorough and accurate batch review / batch disposition. Supports use of quality metrics for functional areas within the organization.
• Conducts investigations into GMP-related issues and the management of the QA change control process.
• Solid understanding of quality management systems, quality metrics, and continuous process improvement principles including global cGMP requirements, and other relevant regulations and guidance to assure quality products. Expertise in medical device or combination product regulations and processes are desirable.
• Expertise in the cGMP requirements pertaining to manufacturing operations in the United States and globally in support of global clinical and commercial production activities for pharmaceuticals.
• Strong organizational and project management skills and focus on delivery of results.
• Good written and oral communication skills
· .• Strong interpersonal skills, with demonstrated ability to work in a multi-disciplinary setting, foster and nurture teamwork, and act as a facilitator to drive fulfillment of corporate strategic goals.
• Ability to anticipate and resolve problems effectively.
Bachelor’s degree in a scientific discipline with at least 8 years of experience in GMP Quality operations, of which at least 5 years of experience supporting clinical phase cGMP Quality operations, with at least 2 years in a leadership role. Additional experience will be considered in lieu of a BS/BA degree.
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