Job Title: Senior Manager, Quality Assurance INTL
Location: Home Based (Anywhere within UK/EIRE) - Belfast, Londonderry/Derry, Dublin, Sligo, Cork, Manchester, Leeds, Liverpool, London, Glasgow, Birmingham, Swansea, Cardiff
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.
As Intercept continues to build its position as the leader in progressive non-viral liver disease, we are seeking a Senior Manager, Quality Assurance International.
The Senior Manager, Quality Assurance International will work remotely from home, and is responsible for managing quality assurance operations and reports to the executive Director of Quality Assurance. It is a full-time position requiring in-depth experience in GMP/GDP. This position is responsible for the quality oversight of CMC activities as they relate to external vendors as well as quality system processes/oversight/management as it relates to internal operations. This position is Quality Operations and pharmaceutical CMO vendor focused and requires knowledge of applicable regulations (both US and international). This position has no reports and may require domestic and international travel.
The successful candidate must be able to perform each of the following satisfactorily:
- Review internal and external/vendor documents for compliance.
- Manage and perform Quality Assurance Batch Record Review to assure the comprehensive review of all manufacturing, packaging, testing, environmental monitoring, inspections, out of specification, deviation and nonconformance documentation pertinent to each batch of product produced for clinical, commercial, or regulatory filing purposes
- Prepare/participate in on-site regulatory audits/inspections, and support vendor audits/inspections, as needed.
- Represent quality in internal and external (vendor) meetings and teleconferences.
- Oversight and management of Intercept (ex-USA) commercial distribution chain - including 3PLs, affiliates, distribution partners.
- Oversee and facilitate the use of Quality Systems, as appropriate; including Vendor Qualification, Quality Event (Exception Management), CAPA, and Change Control Quality Systems including maintaining the log, issuing document numbers, managing the process flow, and generating reports per SOP requirements;
- Maintain/Use the electronic document management (EDMS) system;
- Manage the proper processing of quality documents to ensure their compliance with internal SOPs and applicable health authority regulations;
- Ensure complete Batch Record History file is maintained in EDMS.
- Implementation/improvement of existing Quality Systems and processes to ensure continuously appropriate/compliant execution of operations and processes internally and with external vendors.
- Maintain quality system logs, document archival/storage requirements,
- Perform basic data analyses, prepare quality trend/metrics, and report results against goals.
- Provide leadership as required internally and externally regarding quality interpretation of Regulatory requirements and alignment with ICH Guidelines.
- Provide leadership and expertise to troubleshoot manufacturing deviations and analytical testing issues.
- Other 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
- BS/BA in Organic Chemistry, Biochemistry, or a relevant science
- At least 5 years of pharmaceutical drug QA experience
- Fluent in English, both spoken and written
REQUIRED KNOWLEDGE AND ABILITIES:
- Internal quality operations and collaborative oversight in a GXP regulated environment for pharmaceuticals, relating to product development and commercial manufacturing.
- Excellent knowledge of EU/RoW distribution requirements.
- QA oversight and collaboration with product development/vendors carrying out API synthesis, drug product manufacture, release and stability testing, and packaging and distribution.
- Quality principles and pharmaceutical industry trends.
- Applicable CFR, ICH, and GXP regulations
- Skills in the following areas:
- Strong verbal and written communication skills are essential
- Excellent organization and multi-tasking skills
- Exceptional interpersonal skills, positive attitude, and problem solving capabilities
- Proven meeting planning skills
- Ability to work independently and prioritize with minimal daily instruction
- Ability to think strategically in order to improve current internal and vendor processes
- Hands on writing of internal and vendor quality documents as required
- Proficient in the following areas and computer applications:
- Electronic Document Management Systems
- MS word
- Microsoft office
- Excel with emphasis in trend charting and data analysis.
- Able to act as RP on ICPT licensed would be advantageous.
- Experience of oversight of both API, Drug Product and Packaging would be advantageous.
- Learning agility and 'scalability' to take on increasing responsibility as Intercept grows
- Consistent demonstration and embodiment of company core values: Come Together, Embrace the Challenge, Be Yourself, Keep Exploring, Own the Solution,
- Ability to have fun and thrive in a growing, diverse, and inclusive work environment
This is a fantastic opportunity to join an innovative organization, where you will enjoy a high level of autonomy. Competitive remuneration on offer.
To apply, please send an up-to-date CV and cover letter no later than 17 th November 2021