What are the responsibilities and job description for the Quality Assurance Manager position at Triveni IT?
We are seeking an experienced QA Manager – Quality Systems to oversee and strengthen site quality systems within a GMP-regulated pharmaceutical/medical device environment.
Key Responsibilities
• Own and manage the site Change Control and Document Control systems
• Oversee CAPA, investigations, deviations, and quality records
• Manage the site Quality Records Management Library
• Support internal and external audits and maintain audit readiness
• Monitor and report quality system performance and metrics
• Review and approve GMP documentation and investigations
• Support supplier qualification activities
• Participate in Quality Review Team meetings and cross-functional initiatives
• Support regulatory compliance activities and provide backup compliance oversight
• Support final product disposition and production batch controls
• Train site personnel on quality systems and processes
What We're Looking For
• 8 years of QA/Quality Systems experience preferred
• Experience working in a GMP-regulated pharmaceutical or medical device environment
• Strong experience with Change Control and Document Control
• Hands-on experience with CAPA and investigations
• Experience with TrackWise, Documentum, D2, or similar QMS/document management systems
• Internal and external audit experience
• Bachelor's degree in Chemistry, Engineering, Life Sciences, or related field strongly preferred
• Knowledge of medical device regulations, ISO 13485, 21 CFR Part 820, MDR/EU regulations is a strong plus
• SAP experience is desirable
• Lean/Six Sigma or ASQ auditing experience is a plus
• Supervisory/leadership experience preferred
• Strong communication, organization, decision-making, and cross-functional collaboration skills