Manager/Senior Manager Quality Assurance

Liquidia Technologies
Full time Full day
Morrisville, NC

Company Description



Liquidia Technologies is a biopharmaceutical company transforming the development of new therapies by precisely engineering drug particles. Our proprietary PRINT technology is a simple, elegant solution that solves common problems with drug delivery and efficacy. PRINT technology is a scalable cGMP compliant process that creates particles and can apply to virtually any therapeutic area, molecule or route of administration. Liquidia is bringing more efficient, controlled development capabilities to the industry while enhancing the safety and quality of products for patients. Liquidia is advancing product candidates from its own pipeline. These initial product candidates, LIQ861 and LIQ865, apply the PRINT technology to better drug delivery in inhaled and pain therapeutic areas, respectively. The PRINT technology is also licensed with world-leading pharmaceutical companies that are developing future product candidates.



Job Description




The Manager/Senior Manager, Quality Assurance is responsible for overseeing assigned activities within the Quality Assurance department.  The primary function is to ensure compliance with FDA and other regulatory agency requirements, as well as customer and internal company quality systems requirements.  


Specific Duties, Activities, and Responsibilities



  • Provide phase appropriate Quality Assurance guidance and support for manufacturing, analytical and clinical operations teams

  • Develop and manage corporate processes that maximize efficiency and phase-appropriate compliance while maintaining compliance with FDA and other regulatory agency requirements; identify improvement opportunities and effective strategies for implementation

  • Manage and support regulatory inspection efforts

  • Create, revise, review and approve documentation in Quality Assurance operations, including Batch Records, protocols, investigations, change control, deviations, CAPAs, material release, specifications, and data review

  • Write, edit, review, approve, and implement Standard Operating Procedures (SOPs) and Quality Policies

  • Review and approve validation documentation for site equipment, systems and processes

  • Review and approve raw material and final product release

  • Perform internal systems and compliance audits

  • Manage vendor assessments and external audits

  • Interface with customers and regulatory agencies

  • All other duties as assigned




Qualifications




Education and Experience



  • BS degree in life science or technical discipline

  • 8+ years of relevant work experience in a current Good Manufacturing Practices (cGMP), Good Laboratories Practices (GLP) and/or Good Clinical Practices (GCP) environment with progressive responsibilities

  • Experience in preparation for and support of regulatory inspections preferred




Additional Information




Knowledge, Skills and Abilities



  • Requires thorough understanding and knowledge of documentation and records management, change control and Quality system requirements in support of cGMP, GLP and/or GCP regulations

  • Ability to organize time for multiple tasks in a dynamic environment

  • Ability to work effectively under matrix organization with multiple deadlines

  • Detail oriented with strong interpersonal, oral and written communication skills

  • Work proactively to lead the quality effort at the company


All your information will be kept confidential according to EEO guidelines.

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