Senior Quality Assurance Manager

3 days ago


Reston, Virginia, United States BioTalent Full time

We are seeking a seasoned Senior Quality Assurance Manager to lead our quality control efforts and ensure compliance with regulatory requirements. This is an on-site role that requires a strong background in Medical Device and Drug Manufacturing.

Key Responsibilities

  • Oversee the quality control team to ensure alignment with organizational goals and resolve issues effectively
  • Ensure compliance with cGMP, ISO13485, 21 CFR 211 and 820, and other relevant regulations
  • Manage quality control procedures through subordinate supervisors, ensuring adherence to product specifications and quality standards
  • Supervise Quality Engineering tasks related to the design, execution, and enhancement of complex manufacturing processes
  • Conduct Management Reviews and Annual Product Reviews in accordance with the company's Quality Management System requirements
  • Identify and propose technical enhancements and projects for management consideration
  • Support the qualification process for new or modified raw materials, components, and critical suppliers
  • Act as the designated Management Representative for the organization, representing the company in discussions with regulatory bodies
  • Stay informed on changes in standards across key markets, including the U.S., E.U., Canada, and others
  • Support Lean, 5S, and Six Sigma initiatives related to manufacturing
  • Facilitate the transition of new product processes from R&D to manufacturing, including prototype development and testing
  • Ensure that all drug products are accompanied by appropriate development history documentation and that Master Production Records and Batch Production Records are meticulously maintained
  • Provide direction to vendors and suppliers regarding the procurement of necessary equipment and materials
  • Oversee technical support for regulatory submissions, including US 510(k) and EU Technical File documentation
  • Lead root cause analysis for product failures within Quality Assurance

Requirements

  • B.S. Degree with 5-8 years of experience within Medical Devices
  • Experience with drug product manufacturing
  • Strong analytical and interpretative skills for business and technical documentation
  • Proficiency in mathematical principles, including calculus and advanced statistics
  • Competence in using word processing, spreadsheet, and database applications
  • Knowledge of international drug and device regulations
  • Leadership capabilities and the ability to function as a technical expert


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