Radius Health, Inc.

  • Manager, GMP Quality Assurance

    Job Locations US-PA-Wayne
    Posted Date 4 weeks ago(11/14/2018 9:54 AM)
    Job ID
    2018-1856
    # of Openings
    1
    Category
    Quality - Dept
  • Overview

    Radius Health, Inc. is seeking a GMP Quality Assurance Manager who has the ability to perform in a fast-paced environment under tight deadlines and who has expertise in assuring compliance with FDA CFR Part 210 and 211, FDA 21 CFR Part 820, EU GMP Volume 4, ISO 13485, ICH Q7, Q8, Q9 and Q10.

     

    The incumbent will have responsibility to ensure that all quality management functions are maintained according to GMP requirements. The incumbent will execute Quality Assurance and quality system activities with a focus on Radius’ late-phase development and commercial products, ensuring consistent application of cGMPs. Specifically, they will have responsibilities for execution of quality systems related to complaint management, complaint investigations, CAPA and deviation management and change management.  

    Responsibilities

    • GMP compliance, (to all relevant regulatory requirements), of all products through the product development, regulatory approval and commercialization processes
    • Act as owner of GMP Quality Management System including systems for investigations (manufacturing, complaint), CAPA, change management. Specifically:
      • Investigate and document product related complaints that are submitted through the complaint reporting process
      • Conduct investigations into GMP related issues or problems associated with audits, batch records and complaints. Assists with management of manufacturing deviations, out-of-specification results and investigations
      • Prepare and review and QA change control documentation for changes related commercial manufacturing, testing and facilities Ensure adequate root cause analysis as well as identification and implementation of effective CAPA
    • Support preparation of annual product quality review report
    • Prepare monthly quality metrics for periodic review meetings
    • Support the development of quality systems and associated SOPs
    • Support review of manufacturing and testing records at contract manufacturing sites
    • Identify and escalate compliance issues to Senior Management

    Qualifications

    • Solid understanding of pharmaceutical and medical device quality assurance principles including global cGMP requirements, 21CFR Part 210 and 211, 21CFR Part 820 and other relevant regulations
    • Bachelor’s degree required
    • 7 - 10 years of relevant GMP experience in biopharmaceutical supplier or contract QA
    • At least 2 year’s experience investigating pharmaceutical or medical device complaints
    • Strong administrative skills including Microsoft Office Suite (Word, Excel, PowerPoint)
    • Experience in interacting with multiple functional groups and working on cross functional teams
    • Experience in management and use of electronic quality management systems preferred
    • Ability to travel up to 10% preferred

     

    The work is performed in a typical office environment with heavy computer duties. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually quiet.   Frequent travel required. 

    The physical demands described here are representative of those that must be met by an employee     to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

    While performing the duties of this position, the employee is regularly required to use hands to type, handle paperwork and sort, file or manipulate documents. The employee is occasionally required to stand and walk. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. 

    Specific vision abilities required by this position include close vision, distance vision, color vision peripheral vision, depth perception and ability to adjust focus. 

     

     

     

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