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AD Quality Assurance

Company: Covance
Location: Indianapolis
Posted on: July 14, 2019

Job Description:

Job Overview

  • Assure all systems, processes and their outcomes comply with standards that meet applicable international and national regulations and guidelines, and fulfil client and Covance CLS requirements. International and national regulations include, but are not limited to FDA, EMEA, ICH GCP, CAP, CLIA, New York State, etc.
  • Manage and supervise the North America QA Regulatory Compliance staff.
  • Establish and maintain a quality system to ensure that facilities, equipment, personnel, methods, processes, procedures, records, etc. conform to government regulations and ICH GCP guidelines.
  • Provide GCP, regulatory and quality system leadership and consultation to Covance CLS and it's operation of the laboratory and supporting departments.
  • Assure that departments, functions and systems within Covance CLS are audited in accordance with written SOPs, that the audits are defined within an annual audit schedule, and that they are completed on-time and within budget.
  • Assure that all vendors/third party providers utilized by Covance CLS and having regulatory output and deliverables are subject to the CCLS Global QA Vendor Audit Program.
  • Collaborate with CCLS management to identify quality system improvement opportunities and viable solutions. Supervision and Management:
    • Will manage a North America QA Managers and staff of Indianapolis compliance auditors
    • Provides overall Quality experience and leadership to the North America QA Regulatory Compliance staff and the global QA team.
    • Provide local/global supervision of assigned department/function
    • Provides staff training, mentoring, coaching, and career development
    • Provides direct supervision of management and staff including staff selection and assignment, SOP training, completion of goals, development plans and performance feedback and standards reviews.
    • Establishes and provides atmosphere conducive to teamwork
    • Accountable for resource planning to complete work in a timely, efficient and high-quality manner.
    • Provides recommendations regarding long-range resource planning, system development, budgeting to ensure organization needs are met.
    • Work with Sr. QA management in making decisions regarding approach to be used when responding or handling regulatory agency inspections, questions and follow-up.
    • Participates in strategic planning, design, interpretation and implementation of SOPs and training to ensure compliance with regulatory requirements and guidelines.
    • Provides Quality input for functional groups responsible for Six Sigma initiatives
    • Contribute to process improvement initiatives across organization
    • Ensure the successful and timely execution and participation in audits, as assigned, according to applicable SOP(s) and the Quality Audit Schedule
    • Provide guidance to auditors regarding quality issues relating to the Quality Audit Schedule
    • Identify non-conformances with requirements and provide suitable recommendations
    • Ensure that audit reports are completed in a timely manner and that audit results are communicated to auditees and management
    • Ensure suitable responses and action plans are provided by auditees
    • Escalate to management where resolution of audit findings are inadequate
    • Prepare and ensure executive summaries of audit findings and trending are delivered to management
    • Serve as a backup auditor to other Global QA staff when applicable Special Projects:
      • lead/participate in QA projects/investigations
      • support special projects requiring QA input
      • tracking, trending and analysis of audit findings to drive process improvements
      • Develop and maintain global quality system to recognized standards
      • Maintain awareness of relevant legislation and regulatory guidelines.
      • Provide interpretation to current and new regulations and provide proactive response to proposed rules
      • Direct and/or participate in development of QA processes and SOP
      • Support development of processes and SOPs by process owners outside QA
      • Contribute to the preparation of Time and Cost Estimates
      • Demonstrates effective professional presentation skills, giving presentations to senior management, staff, sponsors, and government regulatory agencies as required.
      • Represents Covance CLS during regulatory inspection or client inspection and activities, both internally and externally
      • Participate in negotiations with clients Education/Qualifications
        • University/college degree, BA/BS (life science preferred) or equivalent experience
        • 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 Experience
          • Minimum of five (5) years experience in the pharmaceutical/CRO industries, with at least four (4) years in the regulatory environment of a clinical laboratory with direct personnel management experience.
          • Strong analytical skills
          • Excellent technical knowledge, understanding and experience in applying ICH/FDA Good Clinical Practices
          • Excellent oral, written and presentation skills
          • Excellent planning and organizational skills
          • Proven interpersonal, collaborative and communication skills
          • Demonstrated ability to handle multiple competing priorities
          • Ability to inspire effective teamwork and motivate staff and employees.
          • Ability to function as a member of a global team

Keywords: Covance, Indianapolis , AD Quality Assurance, Accounting, Auditing , Indianapolis, Indiana

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