Senior Clinical Quality Assurance Professional
il y a 3 jours
Welcome to our team of quality assurance experts where you will play a crucial role in ensuring the highest standards of clinical research.
About the Role:
We are seeking an experienced Senior Clinical Quality Assurance Consultant to join our team at Discover International. As a key member of our quality assurance department, you will be responsible for overseeing the quality of our clinical studies and ensuring compliance with Good Clinical Practices (GCP) and regulatory requirements.
Key Responsibilities:
* Act as QA representative for assigned clinical studies to ensure compliance with GCP and regulatory requirements.
* Provide timely quality-related guidance to study teams and participate in project meetings.
* Contribute to the selection and quality oversight of service providers.
Quality Management System Activities:
* Review and approve major/critical quality events and potential serious breaches.
* Support root cause and risk analysis for clinical research issues.
* Track CAPA activities to ensure timely completion and assess their effectiveness.
Quality Documents:
* Contribute to the creation, review, and continuous improvement of R&D quality documents.
Audits and Inspections:
* Support inspection readiness activities for high-risk studies, including mock inspections and quality assessments.
* Oversee quality control of study documents and coordinate meetings with subject matter experts (SMEs) to manage inspection preparation.
* Monitor risks and remediation actions during inspection preparation, providing regular updates to QA TA Leads.
Training:
* Act as a subject matter expert (SME) for training sessions and review training materials as required.
* Ensure system users are adequately trained for clinical research activities, liaising with trainers and process owners to develop appropriate materials.
Experience and Qualifications:
* Minimum 5 years of experience in Quality Assurance within the pharmaceutical industry, focusing on quality system management, preferably in Research and Development.
* Bachelor's degree in a related field is mandatory.
Preferred Qualifications:
* Corporate-level QA experience in Research and Development is highly desirable.
Benefits:
* Estimated salary: $120,000 - $150,000 per year
* Competitive benefits package including medical, dental, and vision insurance, 401(k) matching, paid time off, and professional development opportunities.
Language: English is the primary language used in this role.
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