Sr. Manager, Quality Compliance Audits

MannKind • Danbury, CT

81d

About The Position

MannKind 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 MannKind, 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 also 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 MannKind'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 MannKind, 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.

Requirements

• 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.
• 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.
• 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.

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 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 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.
• 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.
• 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.

What This Job Offers

• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree
• Number of Employees: 251-500 employees