• Senior Director, Quality Assurance

    Job Locations US-MA-Bedford
    Posted Date 3 months ago(12/10/2018 9:26 AM)
    Job ID
    2018-1160
    # of Openings
    1
    Category
    Quality
  • Overview

    Reporting to the Vice President of Quality Assurance, 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 Senior 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
    •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 complaint, non-conforming materials and processes, corrective and preventive actions, and product quality related risk analysis
    •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
    •Facilitate the setting of both short-term and long-term goals of 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
    •Enable a quality assurance process for product release in the EU working in conjunction with the Qualified Person
    •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
    •Participate in preparation, review and approval of CMC sections of regulatory filings
    •Direct experience with GMP as well as clinical and commercial quality assurance
    •Excellent communication skills, both written and verbal
    •Participate in due diligence audits of potential business partners
    •Demonstrated ability to work effectively in a team-oriented environment
    •Travel may be required

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