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Check out JobsAI Associate Manager, Quality Compliance
Company Name:
MannKind Corporation
Job Overview
MannKind Corporation has an opening for an 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.
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.
Pay Range:
$80,000 - $120,000 per year