QA Manager: Batch & Deviation Execution Lead

incog; Fishers (IN); On-site; USD 90,000 - 130,000; Full time

Job summary

incog is seeking a QA Manager - Batch & Deviation Execution to own the oversight, progression, and on-time closure of batch-impacting deviations across manufacturing operations at our Fishers, IN site. You will drive cross-functional deviation teams, ensure timely investigations and closure, and act as a change agent to improve deviation processes using Veeva Vault QMS.

Ideal candidates will have excellent technical writing, risk-based decision making, and the ability to influence without direct

Qualifications

• Bachelor's degree in science; pharma/biopharm experience preferred.
• Minimum 3 years of QA experience in pharmaceutical/manufacturing.
• Experience owning deviation/quality event closure to deadlines.

Responsibilities

• Own oversight of batch-impacting deviations in Veeva QMS from initiation through closure.
• Drive cross-functional deviation teams to on-time completion across multiple departments.
• Manage the full deviation lifecycle cadence: initiation, triage, investigation, and closure.
• Track batch-gating QMS records and maintain a prioritized workflow.
• Chair deviation and batch-gating review meetings and escalate risks when needed.
• Coach writers on investigation methodology and GMP-compliant documentation.

Skills

Cross-functional collaboration

Technical writing

Problem solving

Project management

Communication

Risk-based decision making

Education

Bachelor's Degree in Science

Tools

Veeva Vault QMS

Job description

incog is seeking a QA Manager - Batch & Deviation Execution to own the oversight, progression, and on-time closure of batch-impacting deviations across manufacturing operations at our Fishers, IN site. You will drive cross-functional deviation teams, ensure timely investigations and closure, and act as a change agent to improve deviation processes using Veeva Vault QMS.

Ideal candidates will have excellent technical writing, risk-based decision making, and the ability to influence without direct