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.
The GCP QA Director/Manager is responsible for performing GCP quality assurance activities to ensure that Calliditas clinical trials and related clinical activities are conducted in accordance with Good Clinical Practice (GCP) guidelines, applicable regulations and Calliditas policies and procedures. The GCP QA Director/Manager works in collaboration with Clinical Operations giving support and guidance within GCP. The GCP QA Director/Manager is also responsible for accurately identifying and communicating compliance risks and overseeing action plans to mitigate risks. The GCP QA Director/Manager reports to the VP, Global Quality Assurance GxP.
Key tasks and responsibilities
GCP support to Clinical Operations teams.
Maintains a contemporary knowledge of current industry trends, standards, and methodologies as it relates to Good Clinical Practice (GCP).
Participate in the implementation and management of IT systems related to the QMS.
Participate and/or leads domestic and international audits for Clinical Investigators, Trial Master Files (TMF), system and/or document audits to ensure compliance to ICH GCP, applicable regulations, and company standards.
Participate in Vendor Qualification activities.
Update and review of procedural documents related to the QMS such as Policies, SOPs and Work Instructions.
Participates as a co-auditor for investigations into scientific misconduct and/or serious breach of GCP, analyzes investigational findings to identify root cause.
As assigned, reviews and approves third party vendor audit reports for content, format, regulatory risks, and compliance with applicable standards.
Identifies and escalates critical quality issues appropriately to VP, Global QA GxP Contributes to the development and implementation of continuous quality improvement initiatives.
Provides inspection support as necessary for Regulatory Agency inspections held at Calliditas offices or Clinical Investigator sites.
Ensure compliance with corporate policies, procedures and the company´s Code of Business Conduct and Ethics.
Take an active role as a Director/Manager to ensure development and delivery of defined targets and initiatives in line with the strategy.
Education and experience requirements
Bachelor’s degree in scientific or allied health field or equivalent.
Minimum 2 years of GCP QA work experience, or relevant comparable background.
In depth knowledge of FDA regulations, EU Regulations and Directives, and ICH GCP guidelines.
Broad knowledge of clinical processes, procedures and electronic management systems.
Experience in the operational conduct of clinical trials and the application of GCP.
Communicates professionally, clearly, concisely and consistently both verbally and in writing to internal and external customers; works collaboratively with key internal and external customers.
Must be able to organize and prioritize work effectively to meet timelines with quality deliverables.
Possess the necessary scientific education and knowledge to manage quality oversight for clinical trials, understands medical terminology, standards of care and disease states to assure the ethical treatment of subjects.
Demonstrates proficiency in managing complex projects, delivering all expected deliverables in a timely manner, and proactively communicating changes in pre-established goals and deadlines.
Ability to travel up to 25% of time.
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!