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Manager, Corporate Quality

Company: Horizon Therapeutics
Location: Glenview
Posted on: September 24, 2022

Job Description:

Working at Horizon is more than a job - it's personal. For us, success is measured by the numbers that matter most - the number of lives we touch, the number we change and those we work tirelessly to help save. We're a team of agile, out-of-the-box thinkers who are inspired to do more because we know we're a part of something bigger. We strive to build meaningful careers at a company whose values we share because when we live up to our potential, we help others live up to theirs.

Position Summary:

This position is responsible for working with global teams, to ensure quality compliance across all business units in accordance with Good Clinical Practice (GCP), Good Pharmacovigilance Practices (GVP), Good Distribution Practices (GDP), Good Manufacturing Practices (GMP) as well as Company standards. The Manager, Corporate and Development Quality will assure the highest quality level of the company processes and products maintaining quality systems. This individual will provide guidance while ensuring appropriate systems and procedures are in place to comply with applicable regulations and guidelines.

Responsibilities:

  • Provide oversight and manage key elements of the Quality Management System (QMS) within the Corporate and Development Quality group in support of R&D, Clinical and Pharmacovigilance
  • Main liaison between Corporate and Development Quality and R&D Compliance and Standards teams with respect to PV and GCP compliance, inspections, metrics, etc.
  • Establish and provide key performance indicators to measure the health of the relevant Quality Systems and programs
  • Develop and maintain a cross functional Quality Plan and global Quality Manual
  • Develop standard operating procedures (SOPs), policies, and systems needed to comply with regulatory requirements
  • Develop/implement continuous improvement processes within the Quality Management Systems
  • Ensure adherence and maintain the effectiveness of the Quality System, including the Subsystems and Key processes that govern various functional areas by promptly addressing non-compliance issues
  • Lead GxP Inspection Readiness Activities in support of global regulatory agency inspections and partner / vendor audits
  • Responsible for gathering and interpreting regulatory intelligence, as well as evaluating internal practices, making recommendations for improvement, and executing against action plans
  • Lead the development and management of GxP risk assessments, CAPA, deviations, change controls, etc.
  • Provide quality leadership on project teams, driving alignment and decision making
  • Work closely with the PV, Clinical functions, and Quality QMS to drive investigation, corrective action, and process improvement
  • Assist in the review and provide input into the quality sections of the PSMF
  • Perform other functions as required

    Qualifications and Skills Required:
    • Bachelor's degree in a science related field
    • 3+ years of relevant pharmaceutical industry experience which includes GVP and/or GCP experience
    • Demonstrates good, general understanding of the GMP, GVP, GCP, and GLP standards and regulatory bodies that regulate our industry
    • Knowledge of QA oversight expectations for GxP activities
    • Experience with CAPAs, trending analysis, and/or GxP audits
    • Detail oriented and commitment to seeing tasks through to completion in a timely manner
    • Experience and comfort in working both independently and as part of a multifunctional team
    • Ability to write comprehensive audit reports and summary documentation for senior management and functional areas responsible for supporting
    • Proven organizational skills and strong ability to prioritize workload
    • Ability to handle high workloads, stressful situations, and deadlines
    • Ability to travel to/from the office to participate in internal audits, team activities, etc. Both domestic and international travel required to conduct site and vendor compliance audits
    • Professional, proactive demeanor
    • Strong interpersonal skills
    • Excellent written and verbal communication skills

      Essential Core Values and Competencies:

      Growth
      • Manages Ambiguity
      • Strategic Mindset
      • Demonstrates Self-awareness
      • Cultivates Innovation
      • Develops Talent
        Accountability
        • Drives Results
        • Ensures Accountability
        • Decision Quality
          Transparency
          • Courage
          • Collaboration
          • Instills Trust

            Horizon Therapeutics plc does not discriminate on the basis of race, color, religion, gender, sexual orientation, national origin, age, disability, veteran status, or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors. Any individual, who, because of a disability, needs accommodation or assistance in completing this application or at any time during the application process, should contact the Human Resources Department.

            Horizon Core Values & Competencies:

            Growth
            • Manages Ambiguity
            • Strategic Mindset
            • Demonstrates Self-awareness
            • Cultivates Innovation
            • Develops Talent

              Accountability
              • Drives Results
              • Ensures Accountability
              • Decision Quality

                Transparency
                • Courage
                • Collaboration
                • Instills Trust

                  Horizon requires all U.S. employees to be fully vaccinated, as a condition of employment, with either Pfizer (fully approved by the U.S. Food and Drug Administration), Moderna or Johnson & Johnson (currently granted emergency-use authorization by the FDA). "Fully vaccinated" is defined as two weeks after your final dose of the Pfizer, Moderna, or Johnson & Johnson vaccine. Horizon will provide medical and religious accommodations as required by law.

                  Horizon Therapeutics plc does not discriminate on the basis of race, color, religion, gender, sexual orientation, national origin, age, disability, veteran status, or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors. Any individual, who, because of a disability, needs accommodation or assistance in completing this application or at any time during the application process, should contact the Human Resources Department.

Keywords: Horizon Therapeutics, Glenview , Manager, Corporate Quality, Executive , Glenview, Illinois

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