• Director, Quality Assurance

    Job Locations US-MA-Bedford
    Posted Date 2 months ago(1/5/2020 4:29 PM)
    Job ID
    2020-1291
    # of Openings
    1
    Category
    Quality
  • Overview

    This position is responsible for overseeing the quality management system supporting production operations, ensuring regulatory compliance to applicable CFRs and international standards, and continued alignment with Ocular standards and strategic quality initiatives. The Director, Quality Assurance will provide leadership and guidance for personnel within quality assurance operations and serve as support and liaison for other departments.

    Responsibilities

     

    • Provide strategic leadership to the quality assurance operations group for sustained quality system programs with a continuous focus on improvement
    • Ensure timely release of clinical and commercial product batches
    • Transition the organizational processes from a single commercial product focus to an R&D organization with continued management and oversight of commercial products 
    • Incorporate QbD (quality by design) into development activities, to ensure successful scale up and commercialization capabilities
    • Integrate efficiencies into the processes for robust and repeatable results
    • Oversee development of personnel within the quality department; direct training programs and prepare employee development plans
    • Ensure compliance with applicable regulations and international quality standards
    • Develop and manage specific programs for customer complaints, non-conforming materials and processes, corrective and preventive actions, and product quality related risk analysis
    • Participate in preparation, review and approval of CMC sections of regulatory filings
    • Facilitate the setting of both short-term and long-term goals for the QA operations group and ensure accountability for achieving results
    • Direct the use of metrics in process monitoring, maintenance of quality attributes, and trending of process performance
    • Provide timely and informative reports to management on product quality status, quality improvement initiatives, and quality management system operational status
    • Lead inspection activities (preparation, conduct, and response) for internal CMC / GMP regulatory inspections
    • Ensure annual product reviews are completed timely
    • Leadership in technical resolution
    • Integration of global quality requirements (including: Asian, European, Latin American, etc.)
    • Enable a quality assurance process for product release in the EU working in conjunction with the Qualified Person
      Participate in change control review board actions as needed, review and approve all critical change control documents, and approve verification and validation protocols with final reports
    • Participate in internal and external audits as requested

    Qualifications

    • BS degree in scientific discipline or related field required; advance-degree-equivalent experience in production and quality management is desired
    • Minimum ten years’ experience in a Quality function with increasing levels of responsibility in the biotech/pharmaceutical industry
    • Direct experience with GMP as well as clinical and commercial quality assurance
    • Excellent communication skills, both written and verbal
    • Demonstrated ability to work effectively in a team-oriented environment
    • Travel may be required

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