Director, GCP Quality Assurance
3 weeks ago
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, GCP Quality Assurance will lead the clinical quality function by supporting and providing oversight of clinical trials and clinical activities, establish and manage clinical quality systems, and ensure GCP compliance. The candidate will be a hands-on and actively involved in executing GCP 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 GCP quality management systems, policies, and SOPs
- Ensure GCP compliance of ongoing clinical trials
- Conduct quality control reviews of clinical protocols, documents, and records, including regulatory filing
- Identify compliance risks and implement risk mitigation, as applicable.
- Monitor, track, and trend GCP non-conformances, deviations, and CAPAs and communicate to management
- Manage GCP audit activities, internal and external, including conducting clinical vendor qualifications, establishing audit schedule, conducting audits, issuing an audit report, and closing out audits
- Ensure clinical documentation in support of TMF is reviewed and archived appropriately
- Establish inspection readiness of clinical programs
- Manage GCP refresher training and provide quality training for GCP staff
- Perform other duties as required
Qualifications
- To perform this role successfully, an incumbent must be able to perform each essential duty satisfactorily. The preferred requirements listed below are representative of the skills, knowledge, and/or abilities required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
- Minimum Bachelor’s degree in a relevant scientific discipline or equivalent
- Minimum of 8 years of pharmaceutical industry experience in GCP-QA
- Extensive knowledge of GCP regulations, ICH Guidelines, FDA regulations and Guidance
- Good working knowledge of GLP in support of non-clinical is recommended
- QA experience in Phase 1-3 clinical trials
- Proven ability to thrive and enable success in a cross-functional and collaborative environment
- Strong communication and interpersonal skills
- 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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