• Fairway Consulting Group
  • Somerville , MA
  • Executive Management
  • Full-Time
  • 5 Walnut St

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Our client is a leading specialty biopharmaceutical company. They have asked us to assist them in their search for a Director, Quality Control.

Major tasks and responsibilities will include:

  • Develops the Good Manufacturing Practice (GCP) and Good Laboratory Practice (GCL) Quality Control (QC) function for the company.
  • Supports the development and implementation of GMP/GLP quality systems.
  • Ensures that the company s testing and control strategy is in compliance with US and international regulations, laws, and guidelines.
  • Provides oversight of third party GMP and GLP contract testing labs.
  • Ensures timely delivery of clinical supplies.
  • Generates reports as necessary to support specification and expiry setting.
  • Ensures successful technical transfer, method validation and routine GMP and GLP testing in collaboration with Analytical Development and external QC test labs.
  • Prepares, analyzes and trends QC data.
  • Supports QC deviations, investigations, analytical method performance trending and works with external testing laboratories on root cause analysis and investigation actions.
  • Participates in regulatory agency inspections, and assists in observational resolutions.
  • Prepares appropriate sections of regulatory filings and performs data integrity reviews
  • We seek candidates with the following qualifications:

  • Requires a Bachelor s degree in Chemistry, Biochemistry, or related discipline.
  • Must have 10+ years of relevant pharmaceutical industry experience.
  • Requires experience validating methods and monitoring commercial method performance.
  • Experience drafting protocols, data reports and QC/QA compliance documents required.
  • Experience with statistical analysis of analytical data and stability studies highly preferred.
  • Must have demonstrated effective time management skills.
  • Must be willing and able to travel up to 20% domestically and internationally.
  • If interested, please email your resume as a Word attachment to us, reference 3779. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.

    Fairway Consulting Group is included in Hunt Scanlon s list of Top 50 Healthcare & Life Sciences Search Firms.

    Associated topics: design, engineering, manufacture, product, product manager, production, program manager, quality

    * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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