QA Audit Manager
INCOG BioPharma ServicesFishers, Indiana, United States
Posted October 8, 2025
Full Time
About the Company
INCOG BioPharma Services specializes in injectable drug product formulation development, analytical method development, process scale-up, and formulation & filling of vials, syringes, and cartridges. The company also offers customized packaging services including labeling, device assembly, final packaging, and integrated storage solutions at various temperature conditions. INCOG's expertise lies in providing comprehensive pharmaceutical solutions that meet the highest quality standards.
Job Description
INCOG Biopharma Services is seeking a QA Audit Manager to lead all audit activities across their sterile injectable manufacturing operations. The role involves shaping audit strategy, interacting with FDA and EMA, and mentoring a team while ensuring compliance excellence and regulatory readiness. This position requires strong leadership and operational skills within a fast-paced CDMO environment.
Requirements
- Lead comprehensive audit programs
- Manage client and external regulatory inspections
- Develop and implement improvements to the audit team's operations
- Prepare audit reports and maintain GMP documentation
Benefits
- Competitive salary
- Opportunity for growth
- Collaborative culture
- Investment in employee development
