Director, (GCP) Quality Assurance
$160,000–$200,000 year
HybridChicago, Illinois, United States
Job Summary
Drive the strategic vision for the clinical Quality Management System (QMS), ensuring robust compliance across internal systems, pharmaceutical CRO operations, and proprietary medical device studies. Act as the primary organizational mentor and subject matter expert on clinical validation architectures, partnering with internal leaders to guide them through complex compliance ecosystems. Lead, implement, and continuously improve the QMS while establishing quality goals and initiatives that ensure adherence to FDA and ICH regulations. Oversee the clinical QA audit program, including the development and maintenance of internal, client, and vendor audit schedules, and manage the clinical supplier/vendor quality qualification framework. Conduct audits of vendors, partners, investigator sites, and Trial Master Files, and host company regulatory GCP inspections. Oversee the clinical quality system document control process, CAPA, and non-conformance programs, providing Executive Management with annual trends and metrics on program status.
Required Qualifications
- University/college degree (life science preferred) in a scientific or technical discipline from an appropriately accredited institution
- A minimum of 10+ years relevant clinical research experience in a combination of research site, biotech or pharma, or CRO experience
- Drug and/or device clinical trials or clinical experience
- Extensive knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs
- Demonstrated ability to handle multiple competing priorities and to utilize resources effectively
- Demonstrated ability to build rapport with team members and clients
- Excellent written and verbal communication skills
- Excellent organization skills, attention to detail and ability to handle multiple competing and changing priorities within tight timelines
- Able to proactively anticipate needs and follow through on all assigned tasks
- Proficient in the Google platform, Microsoft Word, Excel, and modern electronic QMS/clinical trial platforms
Desired Qualifications
- 5+ years of experience in a Leadership role at a CRO, biotech, or pharma company
- 10+ years of previous related GCP QA experience at a CRO, biotech, or pharma company
- Prior experience working for both a Sponsor company and a CRO
- Early phase clinical trial experience
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