Director, GMP Quality Assurance

2 weeks ago

Boston, United States Imbria Pharmaceuticals Full time

Company Overview

Imbria 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 Overview

The 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. Note: This position requires the incumbent to reside in the Boston area.


Responsibilities

  • Develop, implement, and maintain GMP quality management systems, policies, and SOPs
  • Ensure GMP compliance of manufactured drug substance, drug product, labeling, and packaging of clinical materials
  • Conduct review of MBRs and EBRs and perform final product disposition
  • Perform quality management review and approval of Deviations, OOSs, Change Controls, CAPAs and any other related quality records
  • Review and approve product specifications, test methods, qualification/validation protocols and reports
  • Identify compliance risks, perform risk management, and implement risk mitigation, as applicable.
  • Monitor, track, and trend GMP quality systems and establish metrics
  • Manage GMP audit activities, including conducting vendor qualifications, establishing audit schedule, conducting audits, issuing an audit report, and closing out audits
  • Manage investigational product complaints and are investigated to ensure compliance
  • Establish inspection readiness program
  • Manage GMP training and provide quality training as appropriate
  • Perform other duties as require


Qualifications

  • Minimum Bachelor’s degree in a relevant scientific discipline or equivalent
  • Minimum of 8 years of pharmaceutical industry experience in CMC/GMP QA
  • Extensive knowledge of GMP regulations, ICH Guidelines, FDA regulations and Guidance
  • Experience working with CDMOs, vendor selection, and management
  • Proven ability to thrive and enable success in a cross-functional and collaborative environment
  • Strong communication and interpersonal skills (maintain positive relationship and open communication)
  • Ability to multi-task, shift priorities, and work in a fast-paced environment
  • Detail oriented and well organized
  • Team player, professional demeanor, enthusiastic, and self-motivated


This position requires the incumbent to reside in the Boston area. We offer a competitive total compensation package and invite you to consider a career with Imbria

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