Sr. Manager, Quality Compliance Audits

Role Summary

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.

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.

Qualifications

• 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.