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Quality & Compliance Director

Company: Element Materials Technology
Location: Wilmington
Posted on: August 16, 2019

Job Description:

OverviewElement has an opportunity in the Health Sciences Division, for a Director, Quality & Compliance whose primary responsibility is to lead all quality activities with oversight of three Health Sciences laboratories in North America. You will provide direct supervision to the Quality Managers at each facility. In this role, you will also have a great deal of interaction with clients and regulatory authorities, as well as senior leadership.Responsibilities

  • Ensure compliance with the regulations and standards related to US FDA, Health Canada cGMP regulations and ICH guidances, US DEA and Compendial testing expectations for pharmaceutical production, validation and testing

  • The Director will have proven ability to establish and maintain strong relationships with customers, regulatory authorities and other industry contacts. This will enable the incumbent to anticipate changes in the quality/regulatory landscape and adjust processes accordingly. It is critical that this individual possesses the ability to quickly gain the trust and respect of the team, customers and senior leadership within the Division
  • Establish and drive Quality metrics to ensure that activities are consistent with customer expectations, as well as corporate and divisional quality standards
  • Lead Quality strategic planning and set clear objectives for performance and accountability.Work with Quality Managers to track the execution and facilitate completion of events, such as investigations, deviations and CAPAs
  • Support the creation and maintenance of Policies and Standard Operating Procedures
  • Oversee and administer the Vendor Qualification Program including audit logistics, supporting and conducting quality audits and assessments and maintenance of vendor quality records
  • Participate in compliance / risk mitigation and process improvement initiatives

  • Oversee audits conducted by clients and regulatory authorities, including oversight of audit responses
  • Ensure timely revision of Quality Agreements with suppliers and customers
  • Oversee the Quality training program for the Division
  • Participates and advises on adjustments to the Division Quality procedures and processes, as necessary
  • Identifies gaps in quality and compliance procedures that may pose regulatory issues and devise novel solutions
  • Drive standardization of quality procedures and practices within the DivisionMentor, motivate and challenge to drive and develop team members
  • Abide by safe work practices and adhere to general safety policies
  • Up to 30% travel within North America

    Skills / Qualifications

    • 10-15 years of experience managing a cGMP Quality Organization with clear evidence of building and leading successful teams
    • Bachelor's degree in science, quality or regulatory affairs required. Advanced degree would be a plus
    • Advanced knowledge of the cGMP requirements and ICH guidance documents
    • Thorough understanding of USP, EP and other compendial procedures
    • Effective organizational and time management skills with the ability to multi-task and prioritize assignments as needed
    • Ability to work independently and effectively with a wide variety of colleagues, both inter- and intra-departmentally
    • Ability to develop effective solutions for complex problems and gain leadership support for improvement initiatives
    • Ability to manage effectively, setting clear expectations, establishing accountability, monitoring progress and outcomes
    • Must embody the highest standards of ethics and integrity

      Company OverviewWe are Element, one of the fastest growing testing, inspection, certification and calibration businesses in the world.

      We deliver critical services in Materials Testing, Product Qualification Testing, Certification, Device Calibration and Advisory Services to the Aerospace, Oil and Gas, Transportation, Industrials, Fire and Building product, Infrastructure and other leading sectors, where failure in service is simply not an option.

      Everything we do helps our customers to build better products; get their products to market on time; save them time and money; and minimize the risk associated with product development and production.

      Our mission is simple: to be the best testing partner in the world and together we strive towards a common vision of becoming the world's most trusted testing partner.

      We have four values that we strive to live by every single day.

      • Safety - We keep our colleagues and visitors safe
      • Integrity - We act honestly and fairly to do the right thing
      • Excellence - We set new standards of excellence in everything we do
      • Partnership - We work together for the benefit of our customers

        When combined with our mission and vision, the ethos this creates, enables Element to deliver one thing. CERTAINTY. We exist to help make certain that the materials and products we test, inspect, certify and calibrate for our customers are safe, quality, compliant and fit for purpose.Diversity StatementAt Element, we always take pride in putting our people first. We are an equal opportunity employer that recognizes diversity and inclusion as fundamental to our Vision of becoming "the world's most trusted testing partner".

        All suitably qualified candidates will receive consideration for employment on the basis of objective work related criteria and without regard for the following: race, colour, age, religion, gender, national origin, disability, and/or protected veteran status, or other characteristics in accordance with the applicable governing laws.

Keywords: Element Materials Technology, Wilmington , Quality & Compliance Director, Professions , Wilmington, Delaware

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