Clinical Quality Compliance Expert
2 days ago
We are a leading provider of clinical research solutions, committed to delivering high-quality services to our clients. Our team is dedicated to ensuring the integrity and reliability of our operations.
Job Title: Manager, Clinical Quality ComplianceSalary: $120,000 - $150,000 per yearThis role will focus on process development, implementation, and quality assurance in compliance with GCP and regulatory requirements.
Responsibilities:- Point of contact for quality and compliance questions, working closely with QA to ensure alignment and consistent messaging.
- Support teams in identifying and mitigating risks, providing training as needed.
- Prepare teams for regulatory inspections, ensuring adherence to GCP and overall quality standards.
- Contribute to the facilitation of lessons learned and propose process improvements.
- Review critical findings from QA audit reports to suggest process enhancements.
- Develop CAPAs and collaborate with QA for global inspections.
- Support SOP/WI development, reviewing critical documents.
- Measure progress and target results from improvement projects.
Requirements:
- Bachelor's degree
- 5 years of experience in a pharmaceutical or Contract Research Organization company in a Quality role
- Understanding of Clinical Operations activities
- Experience with sponsor/site audits and developing processes/SOPs/WIs
- Strong written and oral communication skills
- Prior Regulatory inspection experience desired
About You:
- Problem-solving and leadership skills
- Knowledge of relevant procedures
- Customer Service mindset
- Team Player/Ability to interact and collaborate with key stakeholders
- Adaptability and ability to drive solutions
- Broad knowledge of Clinical Operations
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