European Product Quality Engineer responsible for handling product quality claims and monitoring Altherma heat pump launches. Collaborating with internal teams across EMEA for quality assurance.
EG
Onsite GCP Director of Quality Assurance and Compliance
Posted 4 days ago
About the role
- GCP Director ensuring compliance in clinical trials for Evolution Research Group. Overseeing quality assurance and operations at the Clinical Pharmacology of Miami site.
Responsibilities
- ensuring that day-to-day clinical trial operations at the CPMI site are conducted in compliance with study protocols, FDA regulations, and ICH/GCP guidelines.
- provides oversight and reporting to Operational Leadership to maintain the integrity and quality of all site activities.
- Conducting internal audits
- Monitoring training completion and associated metrics
- Providing support and consultation for Quality events and CAPAs
- Overseeing and assisting with internal and external audits
- Managing and supervising Quality Control plans and QC staff
- Maintaining all Quality-related activities within the clinic
- supporting the overall Quality Management System for these sites to ensure quality assurance, quality control, compliance, and auditing activities related to study conduct.
Requirements
- Thorough understanding of Good Clinical Practices (GCP), Code of Federal Regulations (CFR), and HIPAA as they apply to clinical research.
- Bachelor’s degree or higher in life sciences, medicine, or a related field (or equivalent experience).
- Bilingual Spanish highly preferred
- Minimum of 10 years in the pharmaceutical, clinical, or medical device industry, including conducting internal and external audits.
- At least 5 years of experience participating in FDA or other regulatory agency inspections (preferred).
- Extensive experience managing CAPA programs with a focus on GCP compliance, ensuring timely completion and deliverables.
- Background in project management, site leadership, or oversight of high-volume clinical trials strongly desired.
- Experience with 21 CFR Part 11 and aspects of Computer System Validation (preferred but not required).
Benefits
- competitive benefits include medical and dental coverage
- a matching 401(k)
- paid time off to recharge
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