Sr. Manager - QC - IAPI - In Process Lab

Key Responsibilities

• Ensure GMP, GDP, and data integrity (ALCOA+) standards are met across all testing
• Deliver in-process results within required cycle times
• Identify, escalate, and investigate atypical results and deviations; drive root cause analysis and CAPA
• Maintain inspection readiness; support audits and pre-inspection reviews
• Review data for accuracy and compliance
• Identify and implement continuous improvement opportunities
• Plan weekly workload and lead daily huddles to track KPIs
• Adjust staffing/resources to hit timelines; troubleshoot equipment and process issues in real time
• Lead investigation teams; partner with QA, Tech Services, and Manufacturing on CAPA
• Set goals, coach performance, and conduct regular 1:1s with direct reports
• Partner with HR/upper management on personnel issues as needed
• Represent QC in cross-functional meetings; share best practices across the network
• Manage lab budget, including POs and invoice approvals

Basic Qualifications

• Bachelor's degree in Chemistry or related scientific discipline
• 3+ years of laboratory experience
• 1+ years in a GMP environment
• 1+ years in a leadership role (team lead, supervisor, or manager)
• 2+ years working with quality/data systems (e.g., LIMS, chromatography software)
• Must be authorized to work in the U.S. without current or future sponsorship