Trina C.
Clinical Compliance and Quality Assurance Senior Leadership
- Role
- Senior Director, Research Quality Assurance at Disc Medicine
- Location
- Franklin, TN, US
- LinkedIn followers
- 500 followers
About Trina C.
I am an Executive Director of Clinical Compliance and Quality Assurance, with extensive…
Experience
Senior Director, Research Quality Assurance
Aug 2024 — Present · Watertown, MA, US
Research Quality Assurance leader committed to driving quality excellence across all stages of research and development for Disc’s pipeline to achieve product realization to facilitate bringing therapies to patients necessary in their disease journey. Oversight of GCP/ GLP regulated activities by providing strategic leadership and direction for Disc’s Quality Management System, ensuring compliance with regulatory standards and driving continuous improvement. Drive strategies for the Research Quality Assurance organization through ongoing assessment of regulatory, industry, and internal/ external trends, determining impact to the business.Develop and implement clinical risk management strategies to identify, assess, and mitigate risks through the conduct of risk assessments, development of risk mitigation plans, and overseeing their implementation. Drive a culture of continuous improvement. Identify areas for enhancement, implement process improvements, and promote best practices to enhance an overall culture of quality, efficiency, and compliance. Consult and partner with the internal quality management team to ensure appropriate focus for audit management activities. Build and implement internal regulatory inspection preparedness and facilitate inspection activity. Establish and monitor quality metrics/ key quality indicators. Prepare regular reports and presentations for executive leadership highlighting quality performance, trends, and areas for improvement.Collaborate with cross-functional teams, including clinical operations, regulatory affairs, pharmacovigilance, clinical pharmacology/ early development, and other relevant departments, to ensure alignment of research quality assurance activities. Build and maintain effective relationships with internal and external stakeholders.
Education
Belmont University
Bachelor of Science, Biology, Chemistry
1997 — 1999
University of North Alabama
Master of Business Administration - MBA, Health/Health Care Administration/Management
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