Mary Morris

About Mary Morris

My name is Mary Morris I have been able to gain experience in interventional, non-interventional, and early access programs. I have worked in therapeutic areas such as oncology, ophthalmology, epidemiology, gastroenterology, neonatology, cardiovascular.I am an excellent candidate for this position because I posses the analytical skills that are required to interpret results and make evaluations. My vibrant personality, and ability to learn quickly will help me to work effectively. I have gained experience working with clients, interviewing candidates, IRB submissions, and regulatory paperwork. My attention to detail, accuracy, flexibility, and self-motivation combined with the ability to learn new techniques and follow instructions are beneficial to my work load.I would like to say that this isn’t personal to me but it is. I have two sisters that have been diagnosed with lupus, and because of the advancement of clinical research and medicine they are both able to live healthy lifestyles. My goal is to help someone feel the way my family felt when my sisters were able to overcome their symptoms.I am a motivated, personable worker with a track record of dependability, hard work ethic, and attention to detail. Ability to learn and apply new technology and work in a fast-paced environment. Tactful team player with the ability to adapt to a changing environment. History of commitment, loyalty, follow-through and reliability. Capable of preparing and maintaining accurate charts within established and approved guidelines. Flexible and versatile – able to maintain quality standards and excellent customer service under pressure.Best Regards,Mary Morris

Experience

1. Quality Compliance Manager

   Amgen

   Mar 2025 — Present

   Plan, conduct and report on risk-based R&D audits• Support the execution of the audit plan for GPvP suppliers/vendors and processes• Support investigations of deviations from GPvP and GCP processes including execution of root cause analysis, design, development or Corrective and Preventive Actions (CAPAs) and Effectiveness Verifications (EVs)• Entering and updating records in the digital quality management system (DQMS) based on investigation and deviation meetings and tracking through to closure• Collating and verifying objective evidence for inspection & audit driven CAPAs/EVsData entry into the risk assessment tool (using risk assessment methodology)• Support Safety and Global Development teams in GxP audits from business partners• Support R&D Quality governance bodies in the clinical development, pharmacovigilance and/or observational research areas• Provide support for audit planning meetings, debriefs, audit plan outlines and response reviews• Maintain knowledge of current regulatory and quality practices/issuesCollate compliance metrics (e.g. audit/inspection data and other significant compliance information) to support presentations to key partners• Support vendor evaluations related to observational research studies and GPvP or GCP vendors• Actively seek and implement innovative and proactive quality oversight methodologies.

Education

• LSU Shreveport

  Master of Business Administration - MBA, Project Management

• Elizabeth City State University

  Bachelor's degree, Chemistry

• Elizabeth City State University

  Chemistry