Working at Horizon Pharma is more than a job – it’s personal. We define success by a different set of numbers: the number of lives touched, the number of lives changed, the number of lives saved. 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 patients live up to theirs.
The Director, R&D Compliance and Standards may be responsible for managing people, processes, and systems that ensure that one or more R&D functions is/are aware of and able to operate in compliance with applicable external standards (laws, regulations, directives, guidance, etc.). The role is also responsible for recognizing, documenting, and assisting in escalating risks relevant to GCP/GLP/GVP activities. The role may be assigned any or all of the tasks and responsibilities listed below.
- Development and/or oversight of assigned R&D controlled documents (policies, procedures, forms, etc.)
- Manage one or more direct reports effectively
- Write plans, reports, and other required documents
- Conduct or oversight of assigned R&D vendor assessments and classifications
- Conduct or oversight of clinical site assessments
- Internal assessments of compliance with external and internal standards
- Issue/Incident and deviation initial investigation and assessments
- Assigned CAPAs and other risk mitigation actions
- Conduct or oversight of R&D personnel training (including evidence of training) on R&D controlled documents and relevant topics
- GCP, GVP, and GLP inspection readiness of Horizon R&D, its vendors, and its clinical investigators/sites
- Updating and maintaining systems and documentation as assigned
- Other projects or tasks as may be assigned
Qualifications and Skills Required:
- Bachelor’s degree in an applicable discipline (R&D, Quality, Regulatory Affairs, or Life Sciences) Advanced degree preferred
- Outstanding knowledge of applicable laws, directives, regulations, and guidance relevant to the conduct and documentation of R & D activities. Certification (even if lapsed) preferred in one or more applicable areas (GCP, GVP, GLP, auditing, etc.)
- At least 8 years of relevant industry experience
- Excellent organizational and problem solving skills
- Compulsive record keeping skills
- Efficient and effective time management skills with ability to successfully manage competing priorities
- Superior written and verbal communication skills including excellent command of English
- Computer skills including proficiency in use of Microsoft products, QMS, and industry specific systems as used or deployed by Horizon
- Ability to sit and stand for extended periods of time
- Ability to carry, handle and reach for objects
- Manual dexterity to operate office equipment, e.g. computer, phones, etc.
- Ability to travel independently
Horizon Pharma 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.