Principal Associate - QA Incoming Batch Disposition

Role Summary

Principal Associate - QA Incoming Batch Disposition. The Quality Assurance Incoming Batch Disposition team ensures patients worldwide receive safe and efficacious drug and device products through quality oversight of site activities. The QA Representative oversees the disposition of incoming materials, components, and raw materials and serves as a technical leader to ensure adherence to Global and Local Quality requirements and that quality systems for the Incoming Batch Disposition process meet GMP standards.

Responsibilities

• Performs batch disposition of raw materials, components, API, and consumables to ensure GMP-compliant release within expected metrics for timely market release.
• Lead, mentor and coach site personnel on quality matters related to the batch/disposition process.
• Provide guidance to ensure robust Quality Systems and GMP compliance.
• Participate in self-led inspections and support during internal/external regulatory inspections.
• Review/approve GMP documents to ensure quality attributes are met (non-conformances, procedures, protocols, specifications, change controls).
• Participate in Six Sigma projects or process improvement initiatives to improve productivity in the Incoming Batch Disposition center/site.
• Maintain a safe work environment and support all HSE corporate and site goals.

Qualifications

• Required: Bachelors or equivalent (Science or Engineering-related degree preferred).
• Required: At least 10 years in the pharmaceutical or medical device industry in QA roles.
• Required: Previous batch disposition experience supporting device, parenteral, or drug substance products/materials.
• Preferred: Legally authorized to work in the United States; no expected sponsorship for employment visa status.

Skills

• Proficiency with Manufacturing Execution Systems (PMX or similar), Inventory Management Systems (SAP or similar), Laboratory Information Management System (LIMS; e.g., Darwin), Deviation Management Systems (TrackWise).
• GMP facility experience; technical decision-making and ability to lead others.
• Strong oral and written communication; team-oriented; detail-focused with quality systems maintenance.
• Regulatory inspection readiness and execution experience; willingness to work overtime as required.
• ASQ Certified Quality Auditor (CQA) preferred.

Education

• Bachelors or equivalent (Science or Engineering related degree preferred).

Additional Requirements

• Position is day shift with rotating weekends.
• Travel up to 10% to Indianapolis, IN for meetings and coordination with global regulatory organizations.
• Flexible working environment at Lilly Research Triangle Park with periodic remote work based on site activities.