At Intercept, our mission is to build a healthier tomorrow for patients with progressive non-viral liver diseases. Intercept's lead product, obeticholic acid (OCA), is a first-in-class farnesoid X receptor (FXR) agonist. OCA, marketed under the brand name \"Ocaliva ® ,\" is approved in the U.S., EU and Canada for certain patients with primary biliary cholangitis (PBC), a rare autoimmune liver disease. Ocaliva ® was the first product to be approved for PBC in over twenty years and our team is proud to have been pioneers in providing the first second-line treatment option to patients with such critical need. The Ocaliva ® launch in 2016 also marked Intercept's successful transition from a development-stage company to a fully integrated commercial organization with continued growth.
In February 2019, Intercept reported positive topline results from the Phase 3 REGENERATE study of OCA in patients with liver fibrosis due to nonalcoholic steatohepatitis (NASH), which impacts the lives of millions of people in the U.S. alone. Currently, there are no available treatments for NASH, and Intercept is among the leading companies focused on the disease.
As Intercept continues to build its position as the leader in progressive non-viral liver disease and pursues its goal of bringing the first approved therapy to patients with NASH, we are seeking an Associate, Quality Assurance - GMP. This position is responsible for GMP operations pertaining to USA Clinical and Commercial Quality Assurance operations.
This position will further develop, manage and continuous improvement the GMP systems, processes and methods to ensure adequate control of Intercept Product within USA.
The GMP Quality Assurance Associate will ensure that Intercept is adhering to cGMP, Industry Guidelines, Regulations, along with Intercept policies and procedures.
Experience and Skills
The successful candidate must be able to perform each of the following satisfactorily:
- Product Executed Batch Review and disposition of both Clinical and Commercial Product.
- Assist with Vendor Master Batch Record reviews / approval
- Maintain GMP compliant systems and processes which control the quality of work and Product Intercept within USA.
- Assist other functional areas with deviations, CAPA, and change controls.
- QA project liaison for technical / supply chain vendor projects.
- Assist with preparedness for government regulatory agency inspections.
- Report significant quality deficiencies and/or risks to QA management.
- Perform other related duties as assigned.
- Understand the legal and compliance environment and drive collaboration with the Legal and Compliance team
- Drive the spirit of \"ONE Team\" across all functions by supporting a team approach to focus on our patients and customers as our top priorities
- Make Intercept a truly desired place to work
- Bachelor's Degree or higher in scientific or related field required
- Minimum of 3 years of experience specific to Quality Assurance GMP
REQUIRED KNOWLEDGE AND ABILITIES:
- Experience in QA of solid dose manufacturing preferred.
- Hands-On Experience in QC Testing / Validation / Tech Transfer preferred.
- Strong verbal and written communication skills are essential.
- Ability to work effectively across a matrix organization.
- Ability to work independently and prioritize with minimal daily instruction.
- Strong verbal and written communications skills
- Learning agility and 'scalability' to take on increasing responsibility as Intercept grows
- Consistent demonstration and embodiment of company core values: Collaboration, Excellence, Innovation, Integrity, Passion, Patient/Stakeholder Centricity
- Understanding the legal and compliance environment
- Ability to have fun and thrive in a growing, diverse and inclusive work environment