Associate Manager, Quality Compliance

MannKind Corporation has an opening for a n Associate Manager, Quality Compliance Audit in Danbury, CT. DUTIES: Perform/lead quality compliance internal and external audits: GMP, GLP, bioanalytical, GCP, Pharmacovigilance/Safety Reporting, and ISO at all MannKind sites in accordance with regulatory standards. Ensure approved/qualified vendors are on the Approved Vendors List (AVL). Ensure projects and audits are completed according to schedule. Perform functions of Supplier Quality by acting as a liaison between MannKind and Supplier's Quality function. Follow up on issues related to specifications, non-conforming material, and deviations. Responsible for generation, issuance, and maintenance of Quality Technical Agreements. Perform data review for regulatory submissions. Perform/participate in FDA readiness activities/audits. Serve as quality representative for vendor selection teams. Report compliance risk to MannKind Senior Management.