• Manager Client Engagement & Quality Assurance

    Job Location(s) US-NJ-Princeton | US-NC-Raleigh-Durham | US-TX-Dallas | US-MA-Boston | US-IL-Chicago | US-CA-San Diego
    Job Number
    Job Category
    Quality Assurance
    Position Type
  • Job Overview

    This position can be field based or office based anywhere in the United States.

    • Assure all systems, processes and their outcomes comply with standards that meet applicable international and national regulations and guidelines, and fulfill client and Covance requirements.
    • Assure that all projects for which Global QA Lead responsibilities have been assigned have an audit strategy agreed and documented in the QA&C central planning system.
    • Assure that audits as defined in the global audit plan are completed on time and within budget including reporting and follow up to closure.
    • Provide local leadership and/or line management as required.
    • This role may be an Individual Contributor or have line management responsibilities


    Essential Job Duties:

    • Special projects
      - lead/participate in QA projects
      - support special projects requiring QA input
      - support QA initiatives associated with tracking, trending and analysis of audit findings
    • Quality Assurance
      - contribute to process improvement initiatives across organization
      - provide support and direction to maintain global quality system to recognized standards
      - participate in development of QA processes and SOPs
      - support development of processes and SOPs by process owners outside QA *Liaison /
    • Representation
      - represent QA on project teams and other internal forums
      - represent QA at client meetings and/or audits
      - act as liaison with clients and/or their third party auditors Supervision and
    • Supervision and Management
      - Provide line management , if applicable
    • Business Development
      - contribute to the preparation of Time and Cost Estimates as requested


    Minimum Required:

    Level of education required (or experience level which may be substituted for level of education). Professional designations/certifications/licenses required

    • University/college degree, BA/BS (life science preferred) or equivalent experience
    • Advanced degree (e.g. postgraduate qualification in quality assurance) or equivalent experience


    Minimum Required:

    3 Years experience in Clinical Quality Assurance, preferably with GCP experience.

    5 Years experience in other professional roles within pharmaceutical/CRO environment.

    Other required work-related experiences:

    • Proven ability to understand, analyze and communicate the impact of global regulatory issues affecting the drug development process
    • Financial understanding of global clinical development budgets
    • Thorough knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs
    • Knowledge of the drug development process from the perspective of a contract research organization

    Preferred candidate with CAPA development experience


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