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Manager, Corporate and Development Quality

Company: Horizon Therapeutics
Location: Deerfield
Posted on: January 24, 2023

Job Description:

At Horizon Therapeutics, we define success by the number of lives touched, lives changed, and lives saved. Our global biotechnology company is made up of agile, out-of-the-box thinkers with a focus on delivering breakthrough medicines to those living with rare, autoimmune, and severe inflammatory diseases. This is the heart of our global mission. Start a career that enables you to live up to your potential and help others live up to theirs. Join us.

The exceptional support we provide patients and communities equally extends to our employees. We offer industry-leading and award-winning benefits, compensation and rewards programs that positively impact all areas of our employees' personal and professional lives.

Position Summary:

This position is responsible for executing quality operational activities for Horizon's pipeline of clinical developmental candidates. Duties include: quality project management, quality management system (QMS) oversight, driving continuous improvement initiatives, quality representation, communication, and management of quality issues with both internal and external partners. Supporting and executing quality operational, strategic and tactical goals for QMS and development product(s) in order to assure the highest quality standards and regulatory compliance.

This team member is primarily responsible for management of elements of the QMS, quality projects, continuous improvement efforts and operational quality system elements of deviations, CAPAs, change controls and product complaints. This team member will also be responsible for tactical product execution activities, such as batch documentation review, batch release, and coordination of QP release through internal or external QPs, as applicable. This team member will also be responsible for ensuring the highest quality standards for the product(s) by the tracking and monitoring of batch, stability and quality control data. This team member serves as the analytical, technical, and quality operational expert for product(s), as needed.

Responsibilities, including but not limited to:

  • Quality Project Management
  • Lead Quality representative for product(s) to internal and external partners
  • Management of QMS elements including investigations, change controls, CAPAs, and product complaints
  • Establishment of phase-appropriate QA procedures and oversight
  • Review of batch documentation and batch disposition of drug substance, drug product, and finished product batches
  • Identification and communication of risks to product, supply, clinical study, or business, propose solutions, escalate and communicate in an appropriate and timely manner
  • Execution and support of internal and external audits
  • Preparation for and participation in regulatory inspections as a subject matter expert
  • Preparation of materials for business reviews and routine operational meetings
  • Quality representative for all product testing and analytical methods
  • Assurance of phase-appropriate method development, qualification, and validation
  • Tracking and monitoring of quality control and batch trending data
  • Assurance of safety, identity, and purity of assigned product(s)
  • Coordination of QP release through internal or external QPs, as applicable
  • Establishment of holistic process control strategy and oversight of process performance qualification
  • Key contributor and/or reviewer of IND, IMPD, NDA, BLA, MAA, NDS, etc. materials
  • Facilitate technical and knowledge transfer to commercial quality team members
  • Drive continuous improvements initiatives within and across product portfolio

    Qualifications and Skills Required:
    • BA/BS in Chemistry, Biology, Engineering or equivalent required
    • 5+ years pharmaceutical experience with at least 3 years in a QA/QC position supporting pharmaceutical production and/or testing
    • Knowledge of ISO 13485 and familiarity with other regulatory requirements applicable to a medical device and combination product development and manufacturing operations
    • Experience with drug development from pre-clinical through commercialization
    • Experience with cGMP manufacturing of clinical trial material
    • Expertise in pharmaceutical product quality
    • Ability to work with high level contact and exposure to sensitive information necessitating considerable use of tact, diplomacy, discretion and judgment
    • Strong written and verbal communication skills
    • Ability to partner effectively with internal and external partners
    • Proficient in Microsoft Office
    • Professional demeanor
    • Self-starter attitude
    • Strong interpersonal skills
      Our Values
      • Transparency: We value collaboration. Trusting teach other and tackling tough challenges can make a powerful difference.
      • Accountability: We do what's right for our patient communities through quality decisions and owning our successes and failures.
      • Growth: We fiercely innovate and evolve to better ourselves, our communities and our patients.

        These three values come to life through our five Leadership Expectations that apply to all Horizon employees
        • Enterprise Mindset: Look beyond one's team, brand or function to see the broader company and external perspective
        • Exhibit Intellectual Curiosity: Seek to understand what you do not know; ask the right questions of the right people and sources
        • Ensure Accountability and Courage: Step up to address difficult issues and hold self and others accountable to commitments
        • Embrace Diverse Perspectives: Welcome others with a respectful attitude; integrate diverse perspectives into ways of working
        • Develop Talent: Provide feedback, coaching and mentorship to help others be more effective in their role

          At Horizon, we know that disease does not discriminate. We embrace the bold ideas of one another, foster a sense of belonging, and value inclusion. We attract and develop diverse talent because we believe that when people from different backgrounds and life experiences come together, we make lives better.

          Horizon intends that all qualified applications are given equal opportunity, and that selection decisions be based on job-related factors. We do not discriminate based on race, color, religion, gender, sexual orientation, national origin, age, disability, veteran status, or any other characteristics protected by law.

Keywords: Horizon Therapeutics, Arlington Heights , Manager, Corporate and Development Quality, Executive , Deerfield, Illinois

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