• Fairway Consulting Group
  • Newton Center , MA
  • Non-Executive Management
  • Full-Time
  • 101 Olde Field Rd

Our client is a clinical-stage biopharmaceutical company. They have asked us to assist them in their search for a Manager, Quality Operations.

Major tasks and responsibilities will include:

  • Oversees quality activities associated with manufacturing, testing, and disposition of clinical materials.
  • Serves as the Quality Operations representative on CMC and CMO project teams.
  • Identifies and provides input on quality issues.
  • Manages review of product release and stability data, supports method transfers and validations.
  • Reviews and approves API, and drug product and packaging batch records.
  • Performs disposition of clinical products in multiple phases of development.
  • Provides quality expertise, advice and/or assistance across the organization, as required.
  • Provides input and support for the development and improvement of quality operations processes.
  • Supports review of CMC documents for regulatory filings.
  • Leads or supports external supplier audits.
  • Establishes and maintains effective working relationships with key internal and external stakeholders.
  • We seek candidates with the following qualifications:

  • Bachelor s degree in life sciences, chemistry or equivalent required.
  • Must have a minimum of 5 years of GMP quality experience in a virtual Pharmaceutical/Biotech setting.
  • Requires strong technical and analytical skills to identify and solve problems.
  • Must have experience managing relationships with contract manufacturers and testing labs.
  • Experience with small molecule and solid oral dosage forms required.
  • Requires experience in early phase development transitioning to registration and commercial.
  • Must have working knowledge of ICH quality guidance, EU and FDA drug manufacturing regulations.
  • If interested, please email your resume as a Word attachment to us, reference 3955. 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.

    * 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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