This position is responsible for managing Quality Systems related initiatives to ensure safe and effective product supply in accordance with regulatory requirements
Job Summary
This position is responsible for managing Quality Systems related initiatives to ensure safe and effective product supply in accordance with regulatory requirements.
The role involves leading the Quality Questionnaire program for suppliers and third-party manufacturers while ensuring accuracy and timely completion.
Candidates must act as a Subject Matter Expert on assigned Quality Systems and provide support for transitions into the Business Unit.
Matching Summary
This position is responsible for managing Quality Systems related initiatives to ensure safe and effective product supply in accordance with regulatory requirements.
Skills & Requirements
Must-have
Manage Quality Questionnaire program
Review supplier quality documentation
Ensure regulatory compliance standards
Lead cross-functional QA teams
Implement corrective and preventive actions
Nice-to-have
Strong stakeholder collaboration skills
Data analytics for strategic action plans
Experience with global initiatives
Advanced written and verbal English
Process owner leadership capabilities
Key Requirements
Bachelor's Degree in Chemistry, Pharmacy, Biology, or Microbiology
5-8 years experience in pharmaceutical or medical device industry
Knowledge of quality system regulations and compliance standards
Proficiency in MS Office suite including Excel, PowerPoint, Visio
Ability to identify quality issues and implement CAPA