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.
This position is responsible for playing a leading role in the quality operational activities for Horizon's pipeline of clinical and developmental candidates. Specifically, this position will be primarily responsible for Person In Plant (PIP) oversight of manufacturing activities related to drug development work. Duties include: quality representation, communication, and management of quality issues with internal partners, (e.g. technical operations, clinical operations, clinical supply, and R&D) and external partners (e.g. CMOs and 3rd party laboratories). Supporting, executing and leading quality operational, strategic and team goals for assigned product(s), as well as establishing strategic plans to optimize both team and company performance in order to assure the highest quality standards and regulatory compliance.
This position is a leading role responsible for the quality operational activities associated with Horizon's clinical and development programs. This position is responsible for ensuring the highest quality standards for the assigned product(s) by providing production oversight and release responsibility for the drug substance, drug product, and clinical packaging of assigned product(s). This person is responsible coordination or execution, as applicable, of QP release. This team member supports and serves as the analytical, technical, and quality operational expert for the assigned product(s) including combination products and/or devices.
Responsibilities, including but not limited to:
Lead quality for clinical and development product(s) to internal partners
QA oversight at CMOs and 3rd Party Labs
Oversight of in-process monitoring, investigations, change controls, CAPAs, and process validation
Lead and communicate risks to product, supply, clinical study subjects, or business, propose solutions, escalate and communicate in an appropriate and timely manner
Execution and support of vendor audits
Own preparation of materials for business reviews and routine operational meetings
Oversight of all product testing, methods, and investigations
Assurance of phase-appropriate method development, qualification, and validation
Execution of clinical product complaint handling, manufacturing investigations, tracking and corrective actions
Tracking and monitoring of quality control data
Tracking and monitoring of batch trending data
Assurance of safety, identity, and purity of assigned product(s)
Review of clinical/development batch documentation and clinical/development batch disposition
Coordination of QP release, as applicable
Key contributor to NDA, BLA, MAA, NDS, etc. preparation
Facilitate technical and knowledge transfer to commercial quality team
Qualifications and Skills Required:
BA/BS in Chemistry, Biology, or equivalent required
10+ years pharmaceutical experience with at least 3 years in a QA/QC position supporting pharmaceutical production and/or testing
Experience with cell culture, biologic purification, parenteral fill/finish, and/or bioassay processes
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
Strong interpersonal skills
Horizon Core Values & Competencies:
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.