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Director GCP, Quality Assurance

Company: Ascent
Location: Mountain View
Posted on: November 17, 2019

Job Description:

Director GCP, Quality AssuranceMountain View, CAJob SummaryThe Director GCP, Quality Assurance, will have the responsibility to serve as a subject matter expert to ensure that all quality and regulatory compliance related to GCPs, pharmacovigilance, and other related activities performed by Medical/Clinical Departments.

  • The incumbent will provide support and promote collaboration to ensure all systems, processes and their outcomes are compliant with GCP guidelines, and applicable international and national standards, regulations and guidelines.
  • Act as a representative during regulatory agency inspections and vendor audits.Essential Responsibilities
    • Assists in the implementation of GXP compliant procedures and operations to ensure a robust quality management system for both the conduct of clinical studies as well as prepare the company to successfully commercialize clinical products
    • Proactively provides GCP QA support to Clinical Operations and other departments based on analysis and interpretation of updates to GCP regulations to assure best Clinical/QA practices
    • Assists with the organization, preparation, coordination, and documentation of regulatory inspections
    • Schedules and conducts Good Clinical Practice (GCP) Audits of systems and processes related to clinical operations, pharmacovigilance and clinical drug development.
    • Provides GCP compliance oversight of internal systems and processes as well as those of CROs, Vendors, and Clinical Investigator Sites.
    • Reviews and provides input to clinical documentation (protocols, study reports, IB)
    • Develops and measures quality metrics to drive consistent quality standards throughout the organization.
    • Other duties as assigned by management?Experience And Qualifications
      • Bachelor's degree is required with 10 years' experience and 5 plus years' experience in Quality Systems related to GCP.
      • Demonstrate ability to effectively communicate and influence the outcomes of the decision making process
      • Analytically strong with practical knowledge of how to identify key performance metrics for quality indicators to set targets for maintaining a state of control while identifying areas for improvement.
      • Extensive experience auditing clinical CRO's, clinical sites and investigator sites.
      • Strong working knowledge and interpretation of FDA / EU and ICH ? GxP regulations and guidelines
      • Broad and direct experience with regulatory authority inspections, including both FDA and EMA inspections
      • Hands-on leader capable of understanding detailed QMS procedures and GxP regulated requirements and expectations
      • Experience working with contract clinical, manufacturing, laboratory and distribution organizations.
      • Capable of collaboratively engaging with external, third parties to effectively ensure the intentions of our Quality System are fulfilled

        Company Description:

        About Ascent:Ascent is a leading national technology consulting and professional services firm that focuses on tactical and strategic consulting. Ascent---s fundamental business is providing staffing services to Large Enterprise clients in our core market verticals: Financial Services, Healthcare, and Life Sciences. We focus the majority of our efforts in Staff Augmentation support of Large Enterprise Clients who utilize a Vendor Management System. Ascent works as both a reliable supplier in support of programs, as well as a Strategic Advisor in support of enterprise efforts to establish best in class preferred vendor programs. Ascent was ranked in the 2007 and 2008 Inc. 500 and recognized specifically for its innovative work in staff augmentation support of Large Enterprise preferred vendor accounts.If you are ready to propel your career to new heights--- read on. We are looking for talented and dedicated colleagues to join our phenomenal team. At Ascent, we have created an environment where culture, commitment and opportunity converge to yield a truly unique place to work. We know that every employee has something important to say and that every employee is integral to our success. Where else can you walk over to a founder and talk about your ideas to help build our business and have that idea implemented in 48 hours? More importantly, we do everything we can to make sure our employees not only have great jobs, but great lives.

Keywords: Ascent, Daly City , Director GCP, Quality Assurance, Executive , Mountain View, California

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