We are searching a QA GCP Director/Manager for Oncopeptides. The company, which is listed on the Stockholm Stock Exchange, was founded in Sweden year 2000 and operates globally. Oncopeptides develops drugs for the treatment of cancer/hematology and is in a very exciting phase of development.
As a QA GCP Director/Manager you will be responsible for performing quality assurance activities to ensure that Oncopeptides clinical trials and related clinical activities are conducted in accordance with Good Clinical Practice (GCP) guidelines, applicable regulations and Oncopeptides policies and procedures.
The QA GCP Director/Manager is part of a QA GCP team and also works in collaboration with Clinical Operations giving support and guidance within GCP.
- Maintain a contemporary knowledge of current industry trends, standards and methodologies as it relates to Good Clinical Practice (GCP).
- The QA GCP Director/Manager is also responsible for accurately identifying and communicating compliance risks and overseeing action plans to mitigate risks.
- Participate in the implementation of IT systems related to the QMS.
- Participate and/or lead 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.
- Update and review of procedural documents related to Quality Systems such as Policies, SOPs and Work Instructions.
- Review and approve third party vendor audit reports for content, format, regulatory risks, and compliance with applicable standards.
- Contribute to the development and implementation of continuous quality improvement initiatives.
- Minimum 5 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.
- You are an excellent verbal and written communicator in both Swedish and English.
Welcome to apply through: www.haegercarlsson.com