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Latitude, Inc. Director of Quality Assurance in Edgewood, Maryland

Job Purpose

The Director of Quality Assurance will help develop, implement, and evaluate quality systems to ensure the organization's combination products and operations meet the quality, integrity, and efficiency standards established by the organization to meet corporate objectives and comply with regulatory requirements for its combination products and operations.

Responsibilities and Duties

  • Provide guidance and oversight of quality assurance staff relative to operations as directed

  • Serve as part of the quality team which oversees all combination product activities

  • Evaluate and execute quality operations from both tactical and strategic perspectives to ensure that products meet quality, integrity, functionality, and other specifications and requirements

  • Collaborate with staff across production departments and roles to develop, draft, implement, and evaluate various quality systems and standards

  • Develop and implement quality systems metrics and evaluation processes, including management reporting procedures as directed

  • Develop, execute and/or review quality assurance documentation as directed

  • Participate in quality audits and self-inspections as directed

  • Report status of quality assurance operations to to the Head of Quality & Regulatory, and others as directed

  • Maintain regular and punctual attendance

  • Perform other additional duties, responsibilities and tasks as directed

Qualifications

  • Minimally a Bachelor's degree in Engineering or related industrial, or life science field required; advanced degrees may be a plus.

  • 10+ years of related experience in the pharmaceutical industry required with at least eight years in a supervisory role; as well as five years as a quality engineer or similar role highly preferred. Pharmaceutical industry experience is a must.

  • Excellent verbal and written communication skills with the ability to train staff

  • Thorough understanding of quality assurance standards and methodologies

  • Thorough understanding of manufacturing and production in ; with a preference for this experience in combination products

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