QA Engineer managing Corrective and Preventive Action program in compliance with regulatory standards. Supporting Quality Management System activities in the Medical Device industry.
EG
Onsite GCP Director of Quality Assurance and Compliance
Posted 5 hours 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
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
Quality Engineer ensuring compliance in aerospace projects, leading audits and design assurance implementation for aviation products.
Quality Engineer ensuring quality of iOS features from design to release at Adobe. Collaborate across teams to validate workflows and improve product quality.
Advanced Quality Engineer ensuring quality requirements in automotive seat production for Mercedes. Collaborating with internal teams and external suppliers during product development and program launch.
Supervising QA associates in PCI Pharma Services ensuring compliance with regulatory standards and effective quality management. Managing external audits and collaborating with production and customer service teams.
Staff Software DQA Engineer leading quality assurance for partner management and integration. Ensuring compliance and interoperability for digital health products at Insulet Corporation.
Senior Design Assurance Engineer ensuring quality and compliance in medical device product development. Collaborating with cross - functional teams on embedded software systems and regulatory requirements.
Advisor in Business Development connecting researchers and industry at Mitacs. Engaging in collaboration to tackle R&D challenges and foster innovation.
Quality Engineer managing quality assurance processes to ensure compliance and traceability at Ingersoll Rand. Collaborating with design, production, and supply chain teams to maintain high - quality standards.
QA Functional role ensuring quality, traceability, and user experience in software delivery for GeoVictoria across multiple projects.