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Quality Manager

Job Type: Full Time

Location: Tacoma, WA

Company
Revalesio is a clinical-stage pharmaceutical company committed to creating novel treatments for acute and chronic neurological disorders that lack adequate therapeutic options. For over a decade, we have been building a strong scientific foundation backing a new approach to developing therapeutics to treat debilitating diseases and improve quality of life. Revalesio’s team is made up of passionate individuals who are inspired to innovate. We partner with internationally renowned scientists and professionals in biomedical research, helping to create a unique and dynamic work environment where everyone is encouraged to share their perspective and provide valuable contributions.

Overview of Role
As Quality Manager, you will play a key role in providing comprehensive quality oversight and guidance throughout the end-to-end manufacturing process of Revalesio’s investigational drugs for clinical trials. Your responsibilities will encompass ensuring compliance with regulations, contributing to the lifecycle of our Quality Management System, and managing the daily work of our Quality Control (QC) and Quality Assurance (QA) teams while building both groups in step with the clinical development of Revalesio’s drug product candidates. In addition, you will be expected to provide innovative input and support to Revalesio’s Manufacturing and Facility teams as well as Management.

Key Responsibilities
  • Oversight of all QC and QA activities, budgets and team members
  • Continually develop our Quality Management System for the manufacturing and supply of investigational new drugs for clinical trials
  • Lead our cross functional, risk management program through monitoring and trending pertinent quality metrics
  • Proactively identify compliance gaps and quality risks and effectively resolve them in a timely manner
  • Conduct all investigations into cGMP deviations, including root cause analysis, CAPAs, and trending
  • Manage cGMP compliance audits, inspections, and interactions with regulatory agencies and ensure our site is always inspection ready
  • Lead inspection and accreditation procedures as necessary, including audit preparation activities and remediation plans
  • Interact with Quality personnel from third parties to import and release Drug Product for clinical administration outside of the US
  • Perform and oversee routine QA duties to ensure Good Manufacturing Practices, such as:
    • Document control (issuance, maintenance, archival)
    • Change control
    • cGMP Training
    • Out of Specification reporting
    • Calibration and maintenance records review and approval
    • Qualification and validation review and approval
    • GMP protocol / report reviews and approval
    • Release of manufactured lots of drug product through the review and approve of completed batch records
    • Internal cGMP audits
    • Oversee Vendor / Supplier qualification, approval, and audits
    • Complaint and recall handling
  • Ensure that all QC testing is robust and done in a timely manner
    • Environmental and utility monitoring
    • Personnel monitoring and gowning qualifications
    • Critical / raw material release testing
    • Drug product testing (lot release and stability)
    • Managing the use of contract labs when needed
    • Any additional required GMP testing
  • Perform other quality related tasks as assigned by the President

Skills / Qualifications
  • Proficient in interpreting global cGMP regulations for both clinical and commercial products
  • Experience with aseptic technique and the cGMP requirements for the aseptic fill/finish of an injectable drug
  • Proficient in the use of MasterControl or a similar GxP compliant electronic Quality Management System
  • Experience with validating analytical methods and biological assays
  • Experience auditing and validating cleanrooms per appropriate standards
  • Experience training staff and building / managing small teams
  • Excellent interpersonal skills in the implementation of CAPAs
  • Excellent writing skills and proficiency with MS Office and the use of Excel or Prism for basic statistical analysis and trending

    • Education and Experience
    • Bachelor’s degree in life sciences or engineering with a minimum of 10 years of experience in a Quality role within the biotechnology or pharmaceutical industries
    • Have at least 5 years of experience managing a Quality Team
    • Experience with in-house drug product manufacturing, labeling, and packaging operations
    • Experience managing cGMP audits conducted by a Qualified Person / competent authority

      • Join us in this critical role where your dedication to quality contribute directly to advancing our mission in biotechnology. If you are passionate about the quality management of pharmaceuticals, we encourage you to apply and become part of our dynamic team.

      Compensation
    $110,000 – $130,000 / year
    Benefits
      We offer a wide range of benefits, including:
    • 401(k) with company match
    • Medical, Dental, and Vision Insurance
    • Paid Vacation and Holidays
    • Potential for stock options
    • Potential for yearly bonuses
    Revalesio Management Inc. is an Equal Opportunity Employer

    Please apply at careers@revalesio.com