David Kihm

Background

About David Kihm

18+ Years of Pharmaceutical / Biotech Experience. Analytical thinker * Analyze and utilize data to provide meaningful metrics for senior leadership in decision making processes * Analyze procedures and processes to identify gaps and implement improvements as needed. Enthusiastic motivator and collaborator * Generate proactive ideas and plans to move away from reactive situations * Mentor and collaborate with cross-departmental staff to improve processes * Present new ideas and solutions with passion and gain buy-in from management to implement positive changes. Manager * Manage quality systems (Deviations & CAPAs)* Manage staff and create positive teamwork environments. Coach and mentor staff to promote independent, motivated employees. Quality Professional * Ensure cGMP is utilized in systems, processes, and procedures * Approve a variety of quality system documents (Deviations, CAPAs, etc) and ensure they meet required compliance requirements Skills/Knowledge/experience * Deviations/Nonconformances * CAPAs * SOP revisions * Change Control * TrackWise database * Cognos * Excel - Tables, Charts, Pivot tables * Data analysis * Metrics - Creation and reporting