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