Sr Specialist, Quality Assurance

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 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 oversight and management of global clinical trial activities, 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 clinical/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 is also 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 is also responsible for working closely with a cross functional team to ensure clinical trial are executed on time with a high level of quality assurance. Responsibilities, including but not limited to:Quality Project ManagementKey quality team member for product(s) to internal and external partnersManagement of QMS elements including investigations, change controls, CAPA, product complaintsFocus on phase-appropriate QA procedures and oversightReview of batch documentation and batch disposition of drug substance, drug product, and packed clinical productIdentification and communication of risks to product, supply, clinical study, or business, propose solutions, escalate and communicate in an appropriate and timely mannerSupport of internal and external auditsPreparation for and participation in regulatory inspectionsPreparation of materials for business reviews and routine operational meetingsAssurance of phase-appropriate method development, qualification, and validationAssurance of safety, identity, and purity of assigned product(s)Coordination of QP release through internal or external QPs, as applicableEstablishment of holistic process control strategy and oversight of process performance qualificationKey contributor and/or reviewer of IND, IMPD, NDA, BLA, MAA, NDS, etc. materialsFacilitate technical and knowledge transfer to commercial quality team membersDrive continuous improvements initiatives within and across product portfolioQualifications and Skills Required:B.A/B.S. in Biology, Chemistry, Engineering or related fields preferred.5+ years of experience with increasing levels of responsibility within the Quality and/or Compliance area.Ability to travel, potential to be international as requiredKnowledge of US and Worldwide GxP regulations and experience with regulatory compliance pliance / QA experience at biopharmaceutical.Extensive experience with electronic GxP systems approaches and implementation of such systems.Proven ability to work in a collaborative team environment across multiple technical functions.Ability to effectively interact with both global functional areas (GxP) and manufacturing sites (GMP) and third-party vendors.Strong organizational skills.Excellent interpersonal skills (including, listening, writing, negotiation, facilitation, attention to detail and presentation skills).Proficient in Microsoft Office.Professional, proactive demeanor.Strong interpersonal skills.Excellent written and verbal communication skills. 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.

Created: 2025-11-15