Associate Director, Corporate and Development Quality

Location
Denver, CO, United States
Posted
Oct 01, 2020
Ref
R0002060
Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
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 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
  • Professional demeanor
  • Self-starter attitude
  • Strong interpersonal 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.