MannKind Corporation · 1 day ago
Sr. Manager, Quality Compliance Audits
Danbury, CT
Full-time
Hybrid
Senior Level, Lead/Staff
$128K/yr - $192K/yr
10+ years expMannKind Corporation is committed to developing and commercializing innovative therapeutic products for patients living with endocrine and orphan lung diseases. The Sr. Manager, Quality Compliance Audits will manage the coordination and preparation of GxP and ISO internal and external audits, ensuring compliance with regulatory standards and assessing compliance risks.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Complete auditor qualification using On-the-Job-Trainings where competency in completing auditing steps/ tasks/activities is demonstrated and documented
Contribute to vendor selection; a process for the identification, evaluation and selection of external providers of goods and services that takes into account quality, business and technology aspects of a vendor's ability to meet defined requirements
Manages the external audit program for vendors and contract facilities that have direct or in-direct impact on a cGMP/1SO/MDSAP process including drug product, delivery system, and related packaging to ensure compliance to requirements, regulations, and standards
Maintains the GLP audit program; approving or reapproving Contract Research Organizations (CROs), and/or GLP vendors for compliance, internal company requirements, and other standards
Maintains the GCP/PV external audit program; audit process of clinical investigators and trial sites, contract research organizations / vendors and related entities providing Good Clinical Practice (GCP) and/or Pharmacovigilance (PV) services to MannKind Corporation
Maintains the approved vendors list; a list of approved vendors, contract organizations and service providers deemed suitable for use based upon auditing performed
Manages quality agreements; contract between two parties that identifies specific, agreed upon roles and responsibilities for assurance of a quality commodity or service. Provide a listing of all current agreements and their status as a component of the Annual Product Review submitted the Agency
Manage supplier change notifications; a notification of a change provided to MannKind by a supplier/vendor that, per the Quality Agreement, does not require MannKind's approval to proceed
Manage supplier relationship regarding non-conforming materials, deviations and CAPA. Develops and utilizes vendor performance metrics of which are reported on in management review
Manages the internal audit program that tracks compliance to internal quality systems and company procedures. Audit program applies to all cGMP/1SO/MDSAP regulated operations and areas
Quality Control (QC) of regulatory submissions; the process for performing review of documents in support of a regulatory submission or clinical quality oversight
Maintenance of regulations, standards, and guidance's - types of documents of external origin
Qualification
Required
BA/BS degree in a scientific discipline with 10-12 years or MS/MBA degree with 6-8 years related experience or the combination equivalent of training and experience
Required knowledge of CFR 210 and 211
10-12 years of experience, preferably in pharmaceutical industry or a regulated environment
Required knowledge of GxP Compliance and ISO standards
Previous management, supervisory, or project coordination experience is required
Proficiency in MS Word, Excel and PowerPoint
Travel 30 to 50 percent
Excellent communication skills both written and verbal
Strong interpersonal skills. Requires the ability to change the thinking of or gain acceptance of others in sensitive situations
Company
MannKind Corporation
MannKind Corporation (Nasdaq: MNKD) is a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions.
501-1000 employees
H1B Sponsorship
MannKind Corporation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (6)
2024 (3)
2023 (2)
2022 (6)
2021 (1)
Funding
Current Stage
Public CompanyTotal Funding
$475MKey Investors
Blackstone GroupDeerfield Capital Management
2025-08-06Post Ipo Debt· $75M
2021-03-02Post Ipo Debt· $200M
2018-12-01Post Ipo Equity· $40M
Leadership Team
Michael Castagna
Chief Executive Officer
Christopher Prentiss
Chief Financial Officer
Recent News
GlobeNewswire
2025-12-24
2025-12-24
MarketScreener
2025-12-24
Company data provided by crunchbase