Quality Audit Manager

Job Title: Quality Audit Manager
Company: Intellectt Inc.
Location: Bloomington, IN
Employment Type: W2 Contract
Pay Rate: $45-50/hour
Work Arrangement: Onsite

Job Summary:
Seeking a Quality Audit Manager to lead regulatory inspections, internal audits, and client audits at an FDA- and EU-regulated aseptic pharmaceutical manufacturing site. Manage five auditors, maintain inspection readiness, and oversee audit responses and CAPAs through closure.

Required Qualifications:

• 7+ years of pharmaceutical Quality, Auditing, or Compliance experience in a GMP environment.
• 3+ years of leadership experience managing teams, projects, quality systems, or compliance programs.
• Auditing experience in an FDA- and EU-regulated aseptic pharmaceutical facility.
• Experience overseeing regulatory inspections, internal audits, and client audits.
• Strong knowledge of global GMP requirements, CAPA, root cause analysis, and risk management.
• Strong leadership, communication, and stakeholder management skills.
• Bachelor's degree required; Life Sciences preferred.
• ASQ and/or RAB auditor certification preferred.

Key Skills:

Pharmaceutical Quality Assurance, Quality Audit Management, GMP Compliance, FDA & EU Regulatory Inspections, Aseptic Manufacturing Audits, Internal Audits, Client Audits, Audit Readiness, CAPA Management, Root Cause Analysis (RCA)

Recruiter Contact:

Rudra Prasad Kunnath
Email:
Phone:

Benefits: Employees hired into this position are eligible for benefits subject to applicable plan terms and eligibility requirements.

• Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for the full cost of insurance premiums.
• Retirement: A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.
• Paid Time Off: No PTO is provided beyond what is required by applicable state and local laws.

Equal Employment Opportunity:

Intellectt Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.