Associate Manager, Quality Compliance

MannKind Corporation

Posted on : 25-07-2025

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1 Vacancy

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Job Location

Danbury, CT - USA

Monthly Salary

Not Disclosed

Salary Not Disclosed

Vacancy

1 Vacancy

Posted on : 25-07-2025

Job Description

MannKind Corporation has an opening for anAssociate Manager Quality Compliance Auditin 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 Suppliers 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: Bachelors 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: Masters 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.

Required Experience:

Manager

Employment Type

Full Time

Company Industry

Key Skills

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About Company

MannKind Corporation

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