Sr. Manager, Quality Compliance Audits

Overview

Mann Kind is committed to developing and commercializing innovative therapeutic products for patients living with endocrine and orphan lung diseases. We are on a mission to give people control of their health and the freedom to live life.

At Mann Kind, our employees are our number one asset, and we foster a tight-knit community where each of us plays a critical role in our collective success. We strive to provide a work environment where diversity of background, thought and perspective is valued and respected. Our team is energized by the company's entrepreneurial spirit that provides an environment in which you can evolve ideas quickly and nimbly.

Our Values serve as the foundation of Mann Kind's culture. They define who we are, how we act, and guide our interactions every day—both with each other and the customers we serve. At Mann Kind, you will work with people who are experts in their fields, see challenges as opportunities, are tenacious and push boundaries, bring creative and solutions-based thinking forward, and always believe in winning together.

Manages the coordination and preparation of GxP and ISO internal and external audits in accordance with the regulatory standards and using sound judgement in assessing compliance risks. Interactions normally involve matters between functional areas or other company divisions/units and customers. Performs audits, act as lead auditor as well as identifies resources and define plans for other auditors.

• 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 indirect impact on a cGMP/ISO/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 Mann Kind 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 to the Agency.
• Manage supplier change notifications; a notification of a change provided to Mann Kind by a supplier/vendor that, per the Quality Agreement, does not require Mann Kind'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/ISO/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.

Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary. As a member of the Quality organization at Mann Kind Corp. the incumbent is also expected to use quantitative reasoning; and to be…