Director, Quality Management Cover Letter

Please consider me for the director, quality management opportunity. I am including my resume that lists my qualifications and experience.

In my previous role, I was responsible for competence in the areas of Process Development, Risk Management/Control, Quality Assurance, Test Development, Statistical Techniques, Quality Assurance and Regulatory Compliance.

Please consider my experience and qualifications for this position:

• Experience in designing and delivering quality systems training
• Understanding of regulatory requirements for validated systems for clinical trial data and documentation management
• Understanding of drug development and biopharmaceutical industry preferred
• Lleadership of Cross-functional initiatives/effective change management of process or technical improvements that improve department standards or practices
• Training in healthcare compliance activities, healthcare safety/risk management, hospital performance improvement activities, and hospital administration preferred
• Completes monthly quality related data entry, analysis and reporting
• Focuses on the importance of employee training and education in the work place
• Works with leadership team to ensure reporting requirements are met

Please consider me for the director, quality management opportunity. I am including my resume that lists my qualifications and experience.

In the previous role, I was responsible for leadership and coordination in the development and implementation of the Quality Assurance and Performance Improvement Plan (QAPI) for UAMS.

Please consider my qualifications and experience:

• Excellent leadership and line management skills
• Strong computer skills including Microsoft Office and Clinical Management applications
• Open to additional training as deemed applicable
• Proficiency with TrackWise is preferred
• Health care quality certification
• Previous experience coordinating institutional processes to maintain compliance with regulatory standards
• Financial management related to budgets and Length of Stay initiatives
• Nursing/Nursing License

Please consider me for the director, quality management opportunity. I am including my resume that lists my qualifications and experience.

In the previous role, I was responsible for oversight and direction for the following: Accreditation by various agencies; Infection control; Performance improvement; Data management.

Please consider my experience and qualifications for this position:

• Provides ongoing regulatory updates on quality management/ performance improvements to the PICG
• Prepares presentation of monthly reports to Joint Conference/ Professional Affairs Committees
• Strong communication skills excellent clinical knowledge and experience in a medical group setting
• Experience and Knowledge in Quality Management in the Clinical Trial setting and Risk Assessment/Management
• Knowledge of Transcelerate, ICH E6, Rev
• Experience in Oncology Therapeutic Area, specifically related to design of trials and therapeutic area knowledge
• Experience developing and delivering effective CAPA management solutions
• Knowledge of Transcelerate and ICH E6, Rev

I submit this application to express my sincere interest in the director, quality management position.

Previously, I was responsible for ongoing regulatory and quality improvement training, guidance, and development opportunities to staff who affect the delivery of care.

Please consider my experience and qualifications for this position:

• Experience and Knowledge in Quality Management in the Clinical Trial setting, GCP Auditing and GCP Inspections with a demonstrated record of accomplishments
• Experience in Oncology Therapeutic Area, specifically related to design of trials and therapeutic area specific clinical assessments and medical practice (Clinical trial management and/or direct clinical trial field monitoring experience (Lead CRA Role)
• Experience in developing and delivering effective Corrective and Preventive Actions (CAPA) management solutions
• Quality Management or QA experience
• Experience in different functions in the clinical development area
• Experience as leader of cross-functional teams
• Sound working knowledge of medical terminology, clinical monitoring procedures (SOPs), GCP, FDA regulations, quality improvement initiatives and processes
• Knowledge of National and International Regulations and Drug Development process

I would like to submit my application for the director, quality management opening. Please accept this letter and the attached resume.

In the previous role, I was responsible for proactive quality support regarding research best practices, document control, process development/improvement, and risk management.

My experience is an excellent fit for the list of requirements in this job:

• Experience with GxP document management
• Experience with GxP IT systems
• Previous experience managing staff (2-3 direct reports
• Demonstrated capabilities in managing/facilitating cross functional project teams in a fast paced, deadline driven environment
• Expert knowledge of cGMP and/or Quality System regulations
• Experience facilitating/managing quality risk assessments using risk management tools in alignment with ICH Q9 guidelines
• Training and/or certification in risk management tools/principles
• Experience with application of process improvement tools and methodologies such as LEAN/Six Sigma, especially in areas of Supply Chain Management, Manufacturing, Engineering, and/or Process Development is highly preferred