Calliditas Therapeutics is a specialty pharmaceutical company based in Stockholm, Sweden focused on identifying, developing and commercializing novel treatments in orphan indications, with an initial focus on renal and hepatic diseases with significant unmet medical needs. Calliditas’ lead product candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of the autoimmune renal disease IgA nephropathy, or IgAN, for which there is a high unmet medical need and there are no approved treatments. Calliditas is running a global Phase 3 trial within IgAN and, if approved, aims to commercialize Nefecon in the United States. Calliditas is listed on Nasdaq Stockholm (ticker: CALTX) and the Nasdaq Global Select Market (ticker: CALT). Visit www.calliditas.com for further information.
We are looking for a Vice President (VP) Quality Assurance (QA) GxP, based in Stockholm. The VP QA is overall responsible for ensuring adequate quality assurance activities within all GxP. The expert role is mainly within Good Clinical Practice (GCP) however the responsibility in the role includes coordination and overall management of all GxP activities and include all these activities in the company audit plan. The role is strategic, global and reports to the CEO. The VP QA is also a part of the Executive Team.
Key tasks and responsibilities
- Develop and maintain the QA department at Calliditas.
- Line management of staff and consultants reporting to VP QA.
- Lead team members, including performance planning and staff development.
- Take an active role as an Executive team member to ensure the development and delivery of defined targets and initiatives in line with the strategy.
- Responsible for QA budget.
- Ensure there is a robust Quality Management System in place in order to fulfill regulatory requirements for clinical trials.
- Responsible for managing/coordinating regulatory inspections related to Calliditas studies.
- Responsible for developing strategic audit plans within all GxP’s.
- Ensure audits are conducted in accordance with the plan, ensure adequate CAPA’s are developed by the auditees in accordance with company SOPs.
- Ensure adequate audit capacities are contracted to fulfill the audit program.
- Ensure appropriate evaluation of CROs and third-party vendors.
Education and experience requirements
- Master’s degree in Scientific or allied health field.
- 5 years of relevant clinical trial experience, and 10 years of relevant QA experience.
- Broad knowledge of clinical processes, procedures and electronic management systems.
- In-depth knowledge of FDA regulations, EU regulations and Directives, MHRA statutory Instruments and ICH GCP guidelines.
- Experience in creating/managing quality systems.
- Leadership/management experience.
- Experience from FDA and EMA inspections is required.
- You are an excellent verbal and written communicator in both Swedish and English.
- Demonstrate proficiency in managing complex projects, delivering all expected deliverables in a timely manner, and proactively communicating changes in pre-established goals and deadlines.
Reasons to join the Calliditas Team
- Be a part of a global leader in IgA- Nephropathy and a rapidly growing clinical-stage pharmaceutical company
- Be a part of the completion of the Nefegard trial and our focus to file for approval with the FDA and EMA
- Get in on bonus and benefit programs
- Fast paced small company environment
Welcome to join the Calliditas Team!