Lead and facilitate Quality Event Investigations and subsequent CAPA development in accordance with defined timelines and in collaboration with appropriate subject matter experts.
Build, deploy and reinforce learning tools and materials to support quality event management capability development.
Oversee the standard and timeliness of deviation and CAPA completion.
Work with the business process owners to identify issues and improvement requirements and lead those improvement initiatives.
In support of the quality management system module leads maintain records of issues, enhancement requests and support the implementation of system changes.
Administer notification to management and escalation process.
Participate in risk assessments and act as risk facilitator.
Candidate Requirements
GxP experience is preferred.
10+ years’ experience in Biopharma experience.
6+ years managing investigations (deviations, CAPA, etc).
Experience writing investigations.
Experience managing RCA.
Self-motivated.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance
Industries
Staffing and Recruiting
Referrals increase your chances of interviewing at Pacer Staffing LLC by 2x