Manager, QMS

MannKind Corporation•Danbury, CT

54d

About The Position

MannKind Corporation focuses on the development and commercialization of innovative inhaled therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases. We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases such as diabetes, nontuberculous mycobacterial (NTM) lung disease, pulmonary fibrosis, and pulmonary hypertension. Our signature technologies - dry-powder formulations and inhalation devices - offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation, depending on the target indication. At MannKind our employees are our number one asset, and we continue to be a tight-knit community where each of us has a critical role in our success. Committed to diversity, at MannKind we depend on a rich blend of ideas, backgrounds, and working styles in our quest to change the world for the better. Summary: Manager of the Quality Management System (QMS) is responsible for the overall development, implementation, and maintenance of the company's quality assurance processes. This leadership role ensures that the organization's products, services, and operations meet internal and external standards, regulatory requirements, and customer expectations. The manager drives a culture of continuous improvement throughout the company. Performs a wide variety of activities within Quality Assurance (QA) to ensure compliance with regulatory and company requirements in support of the Quality Management System. Works under general supervision, following established procedures in accordance with GMP regulations. Works on projects of moderate scope. Exercises judgment using defined procedures to determine appropriate action. Receives general instructions on routine work and detailed instruction on new assignments.

Requirements

BA/BS degree in a scientific or technical discipline with 7-10 years or MS/MBA degree with 5-7 years related experience preferably in the pharmaceutical industry or the combination equivalent of training and experience.
Strong knowledge of quality standards and quality improvement methodologies
Experience in reviewing/writing change controls and document review for regulatory compliance is preferred.
Excellent written and verbal communication skills.
Excellent leadership, communication, and problem-solving skills, with a strong ability to work collaboratively with cross-functional teams.
Ability to work autonomously to problem-solve, demonstrating excellent analytical skills.

Responsibilities

Responsible for supporting QMS functions: Change Management and Document Control
Review and approve change requests and documents for compliance and adherence to company requirements.
Work with change control and document authors to ensure documents are clear, comprehensive and align with other documents in the quality system.
Assess processes and recommend process/system improvements.
Independently resolve issues related to compliance and document quality whenever possible.
Ability to assess impact of change requests, liaison to Change Management Review Board.
Support notification and approval for partner changes.
Author SOPs, change controls and other quality system documents.
Obtain consensus from document approvers.
Provide guidance on compliance issues identified and questions raised by colleagues (inter-departmental and intra-departmental).
Represent QA on various teams and projects.
Perform data entry and execute records in electronic systems.
Collaborate cross-functionally to ensure timely review and approval of Change Controls & SOPs, fostering alignment and minimizing delays.
Track and monitor progress of Change Controls and SOPs to ensure timely revisions and compliance.
Maintain tracking logs and files as required.
Support and/or participate in audits/inspections.
Responsible for observing all Company, Health, Safety and Environmental guidelineQualifications:s.