Quality Improvement Specialist
- Experience Level
- Experienced (non-manager)
Cpl Life Sciences are actively recruiting for a Quality Improvement Specialist to join an exciting and reputable Biotech company. This position will manage the Clinical Review Committee (CRC) process and Investigator usability database. The Specialist will manage the QML Team mailbox to ensure timely management of issue entry and document distribution. The Specialist will manage SSN cases (investigations, root cause analysis, and CAPA management) as assigned. In addition, a key responsibility of this individual is to serve as a business administrator for the electronic Quality Management System (eQMS).
- Manages the CRC and liaises with cross-functional CRC members to ensure timely review and approval of documents to support clinical trial timelines
- Supports the suspected serious noncompliance (SSN) process by managing the QML Team mailbox to ensure issues are entered in Veeva eQMS and documents and queries are handled appropriately and in a timely
- Manages the Investigator Usabillity database within the Veeva eQMS to ensure the list is current and accessible; provides technical support on the use of the database to all Global Development (GD) employees
- Maintain files that support the CRC, issues, and Investigator Usability processes overseen by the Global Development Quality
- Function as a business administrator and expert user for the Veeva eQMS
- Manage SSN cases (investigations, root cause analysis, and CAPA management) as assigned
- Supports closure of CAPA action items
- Supports the Quality Risk Assessment and Control Tracker (QRACT), SPSV process, and protocol deviation trending process as assigned
- Disseminates essential information, status updates, and metrics to management on assigned projects
- Bachelors degree with 4+ years of relevant industry or clinical research experience
- 2+ years experience working in either a clinical compliance group, QA Quality Management/Quality Risk Management function, or Clinical Development with expertise and/or transferrable skills with Good Clinical Practice and Regulatory Inspections.
- Excellent communication skills and ability to work with people in all levels of the organization and externally.
- Excellent technical skills; prior experience with Veeva eQMS
- Demonstrated skills in taking initiative and working independently
- Self-motivated with the ability to work effectively in a dynamic environment with ambuiguity
- Strong leadership with demonstrated ability to interface with senior leaders
- Good problem solving, written and verbal communication skills
- Ability to effectively manage multiple priorities with a sense of urgency
- Strong track record of project management, stakeholder management, collaboration skills and negotiation of complex situations