Dohmen Life Science Services

  • Director, Quality Assurance and Regulatory Compliance

    Job Locations US-TN-Memphis
    Job ID
    2018-2112
    # of Openings
    1
    Category
    Quality Assurance & Regulatory Compliance
  • Overview

    OUR CULTURE: 

    Our Behavior Is Guided By Five Simple Values That Define How We Work And Are The Essence Of What Makes Us Successful

    At Dohmen Life Science Services, an EVERSANA Company , we are committed to keeping our clients for life, ensuring no conflict of interest exists, achieving continuous innovation, and focusing on continuous improvement.

    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?”

    SUMMARY OF POSITION

    The purpose of this position is to develop, implement and maintain the Quality Management System (QMS) to comply with regulations governing Good Distribution Practices (GDP). The most important aspect of this position is to take full responsibility for assuring compliance to all applicable federal (FDA, GDP, DEA, GXP), state licensing, local, ICH, International (where applicable) regulations/standards and client requirements. This position provides tools required to manage, monitor and improve the quality and compliance aspects with the DLSS-three sites in Memphis, TN and Fontana, CA locations. Execution of these activities helps to assure compliance to client and regulatory requirements, and provide tools to foster Performance & Quality Improvement (PQI) efforts.

    The position is also responsible for researching, recommending, and implementing best practices, and contributes to both the strategic and the operational aspects of complying with the GDP regulations. This position is responsible for advising and consulting with all stakeholders about compliance with applicable regulations.

    CRITICAL RESPONSIBILITIES

    Our people leaders are tasked with delivering excellent business results through the efforts of their teams.

    • Setting clear direction, effective plans and measurable outcomes
    • Ensuring work is accomplished effectively by managing employee performance, work processes and other resources
    • Engaging employees to maximize their discretionary effort
    • Developing a pipeline of excellent talent to fill future business needs

    In addition to the critical management and leadership tasks listed above, this role also includes the following unique responsibilities:

    People leaders must possess both the skills to effectively accomplish these tasks and the emotional intelligence to do so in alignment with our cultural values.

    • Establish, oversee and maintain the requirements of the QMS in accordance with applicable regulations
    • Establish strategies to meet QMS business goals and partner with department leadership to ensure goals are met
    • Periodically review the suitability and effectiveness of the QMS with executive leadership.
    • Coordinate Performance & Quality Improvement (PQI) activities, which include assisting with the overall development and implementation of the PQI plan, assisting with the identification of goals and related client/patient outcomes, and coordinating and/or participating in the reporting of activities and outcomes.
    • Establish, oversee and maintain procedures that ensure regulatory requirements.

    ESSENTIAL DUTIES & RESPONSIBILITIES:


    • Strategic Regulatory and Quality planning/execution of Quality and Regulatory plans and Programs.
    • Oversee Standard Operating Procedures, work instructions, forms, templates and other documents associated with the QMS.
    • Develop and implement quality management system processes to ensure the system effectively meets objectives.
    • Design and implement operational initiatives to ensure proper QMS solutions are adopted for the company ’ s present and future business needs.
    • Responsible for providing contractual quality services that are compliant with the regulations governing the services.
    • Acting as advisor to clients on applicable regulations as it relates to federal (FDA, GDP, DEA, GXP), state licensing, local, ICH, International (where applicable) regulations.
    • Support the development of regulatory strategies to expansion of DLSS Service Offering.
    • Participate in planning meetings with management for the purpose of defining regulatory & quality assurance requirements to ensure that the strategies meet the applicable regulatory requirements.
    • Ensure that business and commercial plans meet all federal, state, local, ICH and applicable International requirements to enable the advancement of service and product offerings.
    • Provide insight into the potential regulatory risks and benefits of DLSS responsible location business plans, including directing alternative action plans based on risk/benefit analyses.
    • Review legislative developments to determine changes in regulatory requirements and the probable effects on the company's policies, procedures and activities and then develops appropriate change management techniques to align company processes with new requirements.
    • Identify and address key areas of Process Change and Improvement to improve competitiveness and service delivery excellence.
    • Identification and implementation of performance measurement tools that provide for the improvement of current work practices across the company.
    • Represent DLSS externally in discussions with regulatory authorities in the U.S and with client companies.
    • Manage regulatory inspections; FDA, DEA, State Board of Pharmacy, Local Agencies and International Health Authorities.
    • Manage all client prequalification audits, quality agreements and on-site audits
    • Ensure budgets, schedules, staffing, and performance are met.
    • All other duties as assigned 

    QUALIFICATIONS:

    MINIMUM REQUIRED:

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

    • Bachelor’s degree in Sciences, Engineering or similar field
    • 7 years of Quality Management System processes experience, or equivalent combination of education and experience
    • 7 years Good Distribution Practices (GDP) Management
    • Experience managing regulatory requirements in the pharmaceutical, medical device, biologics industries
    • Experience with Microsoft Office Suite, specifically Word, Excel and PowerPoint.
    • Strong attention to detail
    • Ability to manage multiple priorities and meet organizational goals in a fast-paced environment

    PREFERRED:

     

    • Master’s degree in Sciences, Engineering or similar field
    • 10 years of Quality Management System processes experience
    • 5 years managing regulatory requirements in the pharmaceutical, medical device, biologics industries
    • Extensive knowledge of Good Distribution Practices (GDP) and GMP in the pharmaceutical industry
    • Two or more ASQ certifications

     

    Responsibilities

     

     

     

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