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Director, GMP Quality Assurance

3 months ago

Hartford, United States Imbria Pharmaceuticals Full time

Company OverviewImbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cell’s ability to produce energy in cardiovascular disorders where energetic impairment is a fundamental contributor to symptoms and functional deficits. Our lead investigational product candidate, ninerafaxstat, has completed Phase 2 clinical trials in non-obstructive hypertrophic cardiomyopathy (nHCM), stable angina, and in patients at high risk of developing cardiometabolic heart failure with preserved ejection fraction (pre-HFpEF). In Phase 1 and 2 clinical trials, ninerafaxstat was shown to be well tolerated. Part 2 of our Phase 2 trial, IMPROVE-DiCE, in patients with cardiometabolic HFpEF, is ongoing with topline results expected in early 2025. For additional information, please visit www.imbria.com.

Position OverviewThe Director, GMP Quality Assurance will lead the GMP quality function by supporting and providing oversight of CMC activities, establish and manage GMP quality systems, and ensure GMP compliance. The candidate will be a hands-on and actively involved in executing GMP QA strategy, collaborate cross-functionally with various departments within the organization, and ensure effective communication and constructive working relationships with colleagues and business partners.

ResponsibilitiesDevelop, implement, and maintain GMP quality management systems, policies, and SOPsEnsure GMP compliance of manufactured drug substance, drug product, labeling, and packaging of clinical materialsConduct review of MBRs and EBRs and perform final product dispositionPerform quality management review and approval of Deviations, OOSs, Change Controls, CAPAs and any other related quality recordsReview and approve product specifications, test methods, qualification/validation protocols and reportsIdentify compliance risks, perform risk management, and implement risk mitigation, as applicable.Monitor, track, and trend GMP quality systems and establish metricsManage GMP audit activities, including conducting vendor qualifications, establishing audit schedule, conducting audits, issuing an audit report, and closing out auditsManage investigational product complaints and are investigated to ensure complianceEstablish inspection readiness programManage GMP training and provide quality training as appropriatePerform other duties as require

QualificationsMinimum Bachelor’s degree in a relevant scientific discipline or equivalentMinimum of 8 years of pharmaceutical industry experience in CMC/GMP QAExtensive knowledge of GMP regulations, ICH Guidelines, FDA regulations and GuidanceExperience working with CDMOs, vendor selection, and managementProven ability to thrive and enable success in a cross-functional and collaborative environmentStrong communication and interpersonal skills (maintain positive relationship and open communication)Ability to multi-task, shift priorities, and work in a fast-paced environmentDetail oriented and well organizedTeam player, professional demeanor, enthusiastic, and self-motivated

We offer a competitive total compensation package and invite you to consider a career with Imbria #J-18808-Ljbffr