Sr Manager, Clinical Trials Compliance and Standards

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:

The Senior Manager, R&D Compliance and Standards must have experience in Clinical Trials and is a model of regulatory and quality systems compliance and should function as a subject matter expert and advisor to his or her colleagues throughout the organization.

The Senior Manager, R&D Compliance and Standards works to ensure that Horizon's R&D complies with all internal and external standards (laws, regulations, directives, guidance, etc.) that are applicable to their activities. The Senior Manager, R&D Compliance and Standards works closely with R&D functions to anticipate and prevent issues that may impact R&D compliance. This role may support any or all of the responsibilities and tasks listed below.

Responsibilities:

The expectation is the that Senior Manager, R&D Compliance and Standards is able to perform the following responsibilities and tasks independently, with minimal direction from management:

• Develops and maintains quality systems and controlled documents
• Reviews R&D documents and provides input from a compliance and standards perspective
• Maintains documentation and tracking of Compliance and Standards activities and communications
• Creates tools and training material to support R&D functions
• Plans, arranges, and/or conducts internal and external audits
• Manages partner audit/regulatory inspection readiness and audits/inspections
• Tracks and communicates vendor Key Performance Indicators (KPIs) and other R&D
• Compliance metrics across the organization
• Plans and conducts root cause investigations and analyses
• Manages CAPAs including those arising from deviations and incidents
• As assigned, manages, directs, or mentors, R&D staff, and consultants or contractors
• Understands and works to a risk-based approach, prioritizing the safety and welfare of human trial participants
• Ability to travel independently up to 25% over the course of a year

Qualifications and Skills Required:

• Bachelor's Degree, preferably in healthcare or clinical research
• 5+ years of experience in medical product research and development
• Clinical Trials experience preferred
• Previous experience in a GCP and/or GVP role preferred
• Ability to work under pressure and maintain flexibility
• Attention to detail
• Knowledge of 21 CFR 11, SO, 54, 56, 58, 312, and 812 as well as ICH E6R2
• Strong analytical skills
• Proficient in Microsoft Office
• Professional, proactive demeanor
• Strong interpersonal skills
• Strong 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 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.