Jeffrey A. Conant
Senior Director of Quality Operations @Nimbus Therapeutics
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WORK HISTORY
Senior Director of Quality Operations @Nimbus Therapeutics
Responsible for leading and managing the strategic and operational performance of the Quality function ensuring the successful delivery of business strategy, Key Performance Indicators (KPIs) and objectives, while adhering to regulatory compliance. • Developing and implementing the Quality function to ensure it meets the business requirements, as well as ensure functional performance against objectives. • Implement and maintain all Quality systems to ensure compliance with applicable regulations/guidelines covering GCP/GMP/GxP for Investigational Medicinal Products (IMPs) for human use. • Implement and maintain a Quality Risk Management System to ensure that risks are adequately addressed/mitigated. • Point of contact for all Quality matters, internally and externally. • Ensuring the development of appropriate SOPs (writing/revising/approving), ensuring regulatory compliance in conjunction with being “fit for purpose” operationally. • Ensuring all activities are performed in accordance with GCP/GMP/GxP, company SOPs, applicable laws and regulations. • Ensure supplier and subcontractor audits are performed and reported, as scheduled. • Managing all validation activities, including validation strategy, approval of protocols and reports. • Maintaining awareness of new and proposed regulations and guidelines that may impact the business; communicate those changes to the Senior Management Team as needed. • Prepare, review, and approve Technical and Quality Agreements. • Ensuring appropriate investigation of discrepancies, errors, complaints, failures, or adverse events requiring documented review and action. • Coordinating regulatory authority inspections.
EDUCATION
Cambridge College
Master of Management (MMgt), Finance
UMass Boston
Bachelor of Science (BS), Biology
ABOUT JEFFREY A. CONANT
Accomplished quality leader with deep and broad experience leading teams, implementing…
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