QA Compliance Audit Lead

MannKind Corporation; Danbury (CT); On-site; USD 85,000 - 140,000; Full time

Job summary

MannKind Corporation is seeking an Associate Manager, Quality Compliance Audits to lead internal and supplier audits, investigate gaps, and manage CAPAs across CGMP/ISO/MDSAP processes. You will work with cross-functional teams, support regulatory interactions, and maintain vendor and quality agreements.

Role requires strong GxP knowledge, audit experience, and travel up to 25%. Join a collaborative, science-driven environment focused on patient-centric therapies.

Qualifications

• 4–6 years of related experience in pharmaceutical or regulated environments.
• Knowledge of GxP requirements and ISO standards.
• Hands-on experience conducting or supporting quality/compliance audits.
• Strong communication and cross-functional influencing skills.
• Ability to travel 10–25% for onsite audits.

Responsibilities

• Plan, execute, and report internal and supplier audits.
• Investigate compliance gaps and track audit findings.
• Oversee root-cause analyses and CAPAs.
• Support inspection readiness and regulatory interactions.
• Qualify auditors through on-the-job training.
• Contribute to vendor selection and external audit programs.
• Maintain approved vendor lists and quality agreements.
• Assist with supplier change notifications and nonconforming materials.

Skills

Quality audits

CAPA management

Regulatory knowledge

Vendor management

GxP compliance

GCP/PV awareness

Communication skills

Cross-functional collaboration

Education

Bachelor's degree in a scientific discipline

MS/MBA (optional)

Job description

MannKind Corporation is seeking an Associate Manager, Quality Compliance Audits to lead internal and supplier audits, investigate gaps, and manage CAPAs across CGMP/ISO/MDSAP processes. You will work with cross-functional teams, support regulatory interactions, and maintain vendor and quality agreements.

Role requires strong GxP knowledge, audit experience, and travel up to 25%. Join a collaborative, science-driven environment focused on patient-centric therapies.