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 marketed under the brand name \"Ocaliva ® \" in the U.S., EU and Canada for the treatment of patients with primary biliary cholangitis (PBC), a rare autoimmune liver disease. Ocaliva ® was the first medication to be approved for PBC in over twenty years, and sales continue to grow more than four years after its initial approval in 2016.
Intercept has also established the leading clinical development program in advanced fibrosis due to nonalcoholic steatohepatitis (NASH), a disease that impacts the lives of millions of people in the U.S. alone. Currently, there are no available treatments for NASH, and the REGENERATE study of OCA remains the only Phase 3 trial to have generated positive results in the disease. A second Phase 3 trial, REVERSE, is evaluating OCA in patients with compensated cirrhosis due to NASH, with results expected in 2021.
People at Intercept are passionate about patients. You'll see their photos lining our walls and hear their stories in town halls. We're equally passionate about our team and ensuring each member reaches their potential. We brave new challenges together. That's how we find better ways to get things done and break down barriers. It's also how we make it fun to work here.
At Intercept, we foster an environment that celebrates creativity, collaboration and mutual respect. We never hesitate to lean on our teammates and work together. Our relatively small size means you partner with accessible leaders who know you by name. This brings accountability and growth, which all add up to more opportunities to learn something new every day. A strong commitment to diversity, equity and inclusion is engrained in both our culture and our business. For self-motivated leaders who are ready to make a difference in the lives of patients, Intercept is a great place to be.
Intercept Pharmaceuticals is looking for an experienced GCP Quality Assurance Director. The position will be responsible to assess compliance with Intercept standard operating procedures, GxP, European regulations, local regulations and guidelines, and clinical study protocols. This position will collaborate with Clinical Development, Clinical Operations, Medical Affairs, CROs and Clinical Research Sites to provide quality and compliance oversight of Intercept global clinical trials. This person is expected to play a leadership role in the global inspection readiness strategy. Responsibilities include strategic management of audits; internal systems, vendors/suppliers, and of clinical trial sites. We are looking for a candidate with strong communication skills (written and verbal), with the ability to build internal and external relationships.
The successful candidate must be able to perform each of the following satisfactorily:
- Maintain GCP/ICH compliant systems and processes which control the quality of work and clinical trials conducted by Intercept globally.
- Serve as compliance expert on Intercept clinical SOPs and support continuous process improvements.
- Collaborate with Clinical Operations and Development on quality and compliance strategy via representation on the study teams, and leadership on issue management and escalation to Senior Management.
- Manage the risk-based audit planning for Intercept studies globally to prioritized patient safety, data integrity and regulatory compliance to develop the annual audit plan.
- Execute the audit plan and ensure adequate CAPA Development, Effectiveness Checks and Oversight, Quality Management Reviews. Internal Audit Plan includes clinical investigator sites, vendors, internal processes and GCP systems.
- Drive CRO quality agreements aimed at ensuring quality standards are established, effectively monitored and issues are resolved promptly and effectively.
- Represent Intercept on Joint Quality initiatives with Clinical CROs and Vendors to provide quality oversight of the relationship and compliance with the Quality Agreements.
- Report significant clinical quality deficiencies and/or risks to QA senior management.
- Lead efforts to prepare company and clinical sites for government regulatory agency visits to include local and potentially foreign government agencies; participate as Subject Matter Expert during regulatory GCP inspections.
- Support training of Intercept staff on Intercept procedures, GCP regulations, and documentation systems to assure compliance with company policies and regulatory standards as it relates to Clinical Quality.
- 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.
Experience and Skills
- Bachelor's degree in science or relevant field
- Minimum of 15 years of experience in a regulated environment related to pharmaceutical/biotech industry; experience in Clinical Quality Oversight required
- Minimum of 10 years of experience specific to Quality Assurance GCP
- Minimum of 5 years in GCP Management role.
REQUIRED KNOWLEDGE AND ABILITIES:
- A strong understanding and knowledge of GCP/ICH regulations and an ability to apply them to clinical research and/or related processes is required.
- CAPA Development and Management experience.
- Inspection experience in hosting regulatory authority inspections.
- Excellent organization and multi-tasking skills.
- Exceptional interpersonal skills and problem-solving capabilities.
- Proven negotiation skills.
- Strong proficiency in people and program management.
- Ability to work effectively across a matrix organization.
- Ability to work independently and prioritize with minimal daily instruction.
- Ability to think strategically in order to improve current processes.
- 20% travel is expected.
- 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
- Ability to have fun and thrive in a growing, diverse and inclusive work environment