QA Compliance & Audits Lead (Associate Manager)

Mannkind Corporation; Danbury (CT); Sur place; USD 84 000 - 126 000; Plein temps

Résumé du poste

MannKind Corporation in Danbury, CT is seeking an Associate Manager, Quality Compliance Audits to plan, execute and report internal and supplier audits. This role partners with cross-functional teams to investigate compliance gaps, track audit findings, oversee root-cause analyses, and manage CAPAs, while supporting inspection readiness and regulatory interactions.

You will participate in external vendor audits and GMP/ISO/MDSAP programs, maintain vendor lists, and assist with quality

Qualifications

• Bachelor’s or higher in a scientific field; pharma/regulated environment preferred.
• Strong knowledge of FDA/ISO/GxP requirements and 21 CFR Parts 210, 211, 820.
• Experience planning, executing, and reporting audits; CAPA tracking and closure.
• Excellent written and verbal communication; cross-functional collaboration.

Responsabilités

• Plan, execute, and report internal and supplier audits.
• Investigate compliance gaps and track audit findings.
• Oversee root-cause analyses and CAPA activities.
• Support inspection readiness and regulatory agency interactions.
• Maintain approved vendor list and assist with quality agreements.
• Travel 10–25% for on-site audits.

Connaissances

Auditing

Regulatory knowledge

Communication skills

Travel readiness

Formation

BA/BS or MS in a scientific discipline

Description du poste

MannKind Corporation in Danbury, CT is seeking an Associate Manager, Quality Compliance Audits to plan, execute and report internal and supplier audits. This role partners with cross-functional teams to investigate compliance gaps, track audit findings, oversee root-cause analyses, and manage CAPAs, while supporting inspection readiness and regulatory interactions.

You will participate in external vendor audits and GMP/ISO/MDSAP programs, maintain vendor lists, and assist with quality