Associate Manager, Quality Compliance - BioCT Innovation Commons : Job Details

MannKind Corporation has an opening for a n Associate Manager, Quality Compliance Audit in Danb ury, 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. MINIMUM REQUIREMENTS: Bachelor's degree in Chemistry, or related pharmaceutical sciences field, or foreign equivalent. 4 years of experience in position offered, or related role in pharmaceutical medical device industry or regulated environment. 4 years of experience with GxP Compliance and ISO standards. ALTERNATE REQUIREMENTS: Master's degree in Chemistry, or a related pharmaceutical sciences field, or foreign equivalent. 2 years of experience in position offered, or related role in pharmaceutical medical device industry or regulated environment. 2 years of experience with GxP Compliance and ISO standards.