Eblex Group · 8 hours ago
Associate Director Clinical Quality Assurance
United States
Full-time
Remote
Lead/Staff, Director/Executive
10+ years expEblex Group is supporting an innovative biotech in finding their next Associate Director of Clinical Quality. This vital role involves providing strategic leadership for Clinical Quality and ensuring robust GCP compliance across global clinical development activities.
Staffing & Recruiting
Hiring Manager
Shaun B.
Responsibilities
Provide strategic leadership for Clinical Quality, ensuring robust GCP compliance across global clinical development activities
Act as the subject matter expert (SME) for GCP and applicable clinical compliance regulations and guidelines, including FDA, EMA, and ICH
Build strong, collaborative partnerships with key stakeholders, including regional study teams and global clinical operations and compliance functions
Support and execute the GCP audit programme, conducting routine audits of clinical investigator sites, vendors, processes, systems, and study documentation to ensure data integrity and compliance with internal procedures and regulatory expectations
Provide Clinical QA oversight and review of GCP protocols, Informed Consent Forms (ICFs), Clinical Study Reports (CSRs), and other study-specific clinical documents, as required
Qualification
Required
Bachelor's degree in Life Sciences with 10+ years of progressive experience in global quality and regulatory compliance within the pharma, biotech, or medical device industries; hands-on clinical quality operations and quality systems experience strongly preferred
Demonstrated experience supporting Phase I–IV clinical trials, with particular emphasis on early-phase (Phase I) studies; experience with regulatory submissions and/or approvals preferred
Proven experience leading and supporting regulatory authority inspections, working cross-functionally to prepare teams and effectively engage with regulators
Strong experience developing, reviewing, and maintaining SOPs, and ensuring clinical, regulatory, and medical processes are accurately reflected within the Quality Management System
Broad knowledge of risk-based quality management approaches aligned with ICH E6 and ICH E8
Strong business partner with the ability to collaborate effectively and drive results in a fast-paced environment
Highly self-motivated, detail-oriented, and well-organised, with a proven ability to manage multiple priorities simultaneously
Solid understanding of applicable global industry regulations
Ability to resolve day-to-day quality and compliance issues efficiently while maintaining regulatory compliance
Preferred
Auditor certification(s) desirable
Company
Eblex Group
We specialise in bringing together two worlds; Life Sciences and Technology and connecting the talent that drives innovation across them creating a faster, smarter, and more valuable experience for both clients and candidates.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase