Dohmen Life Science Services

  • Director, Quality Assurance

    Job Locations US-CA-Emeryville
    Job ID
    2018-2103
    # of Openings
    1
    Category
    Quality Management Systems
  • Overview

    OUR CULTURE:

    At Dohmen Life Science Services, we are committed to keeping our clients for life, ensuring no conflict of interest exists, achieving continuous innovation, and focusing on continuous improvement.  Our behavior is guided by five simple values that define how we work and are the essence of what makes us successful:

     

    Caring: We are empathetic and respectful.  We ask “How can I help you?”

    Committed: We are dedicated and persistent.  We ask “How can I make it happen?”

    Creative: We are inventive and imaginative. We ask “How can I do it better?”

    Collaborative: We are cooperative and share our knowledge. We ask “How can we achieve success?”

    Courageous: We’re willing to risk failure over inaction. We ask “How can I challenge myself?”

     

    THE POSITION:

    The most important aspect of this position is to take responsibility to assure compliance to client and regulatory requirements, and provide tools to foster Performance & Quality Improvement (PQI) efforts, support and assist in the development and management of quality systems at DLSS – Emeryville in addition to conducting independent internal and external audits and to assess compliance with regulations, guidelines and operating procedures.

     

    Responsibilities

    ESSENTIAL DUTIES & RESPONSIBILITIES:

    • Continuously identify opportunities to improve operational processes, build in quality and assist in implementation across and within the DLSS – Emeryville location
    • Help to ensure that DLSS – Emeryville quality systems meet or exceed best practices and regulatory standards and participate in development strategies and plans to maintain and improve these systems
    • Live the DLSS corporate values of caring, creativity, commitment and collaborative behavior
    • Provide support and assist in the development and management of GxP (i.e., GVP, GCP, GDP, GAP) activities and quality systems at DLSS – Emeryville, including conducting independent internal and external audits to assess compliance with regulations, guidelines and operating procedures
    • Lead the implementation and support compliance documentation and controls within a standard quality management system across DLSS – Emeryville
    • Support activities to evaluate regulatory compliance
    • Provide support for Company regulatory GxP inspections, client qualification audits and routine/ad hoc audits; conduct external qualification and ongoing audits of vendors and client partners as needed
    • Provide client quality system and quality gap analysis consultation as requested
    • Partner with senior leadership to develop GxP audit strategy and implement inspection and audit readiness activities
    • Help prepare inspection and audit responses and ensure tracking of corrective actions to closure
    • Ensure that post inspection/audit commitments are tracked and completed on time
    • Assist in the implementation of corrective/preventive action plans and quality system improvements
    • Interact professionally with company management, internal departments, third parties and others relative to various quality initiatives
    • Recommend changes in standard procedures to reflect technological changes, regulatory trends and best practices
    • Provide support for collaborative efforts with Dohmen Corporate Quality leadership in overarching corporate quality initiatives

    The above list reflects the general details necessary to describe the principle and essential functions of the position and shall not be construed as the only duties that may be assigned for the position.

     

    An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

    Qualifications

    MINIMUM qualifications:

    The requirements listed below are representative of the experience, education, knowledge, skill and/or abilities required.

     

    • MS, MPH, PhD or similar advanced professional Degree in healthcare or the life sciences preferred Minimum 7+ years in quality assurance in GxP environment (i.e., GVP, GCP, GDP, GAP)
    • Experience in pharmacovigilance and/or medical communications preferred.
    • Minimum 7+ years of experience in conducting audits.
    • Ability to communicate effectively at all levels of the organization and with key client and vendor stakeholders
    • Ability to align internal practices and partner across DLSS – Emeryville for high performance

    Preferred qualifications:

    • Advanced professional Degree in healthcare or the life sciences preferred
    • Knowledge of quality assurance in GxP environment (i.e., GVP, GCP, GDP, GAP)
    • Experience in designing and implementing quality systems and procedures and audit conduct/readiness for the pharmaceutical and biotechnology industry or Quality Certifications
    • Knowledge of Microsoft Excel, Word, and PowerPoint, LMS, TrackWise

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