The Director of Clinical Quality plays a lead role in the development of the operational strategy to ensure clinical studies are conducted in a compliant manner and data integrity is maintained. The Director leads and facilitates operational and continuous improvement of Albireo’s Clinical Quality systems. The Director will create a strategic oversight plan, develop standards, create processes and work with Clinical Operations and Contract Research Organizations (CRO) to establish efficient risk-based quality systems that allow fast and flexible compliant development activities.
The Director will additionally assist in monitoring adherence to regulatory requirements (ICH, FDA, EMA, etc.) and GCP guidelines. He/She leads efforts to identify potential compliance and operational risks to Albireo clinical trials and facilitate the development of mitigation strategies with the assistance of Clinical Development and QA personnel. The goal is to assure the high quality of our operations and services aiming to the long-term success of our business.
Key Duties and Responsibilities:
- Serve as subject matter expert concerning GCP and provide compliance guidance to internal personnel within Clinical and Quality departments
- Establish efficient vendor and site oversight operations to ensure a continuous awareness of the state of compliance for each study
- Lead the development of operational strategies to ensure the creation of flexible policies and procedures related to clinical research oversight and compliance, with a focus on efficiency and speed
- Lead efforts to include adequate quality elements into each study plan provided by the CRO partner to ensure adequate quality oversight
- Partner cross functionally with Clinical Operation and CRO subject matter experts to evaluate areas for process improvements
- Collaborate cross functionally to ensure the implementation of required procedures, best practices and adherence regulatory requirements, and GCP guidelines
- Develop and deliver relevant training to Albireo Clinical Development staff, for example annual GCP training, SOP training, etc.
- Manage strategic/compliance risk assessments, evaluate metric reporting, and facilitate root cause analysis and CAPA process implementation and effectiveness checks
- Liaise with Clinical Development, CRO, and Clinical sites to conduct and support GCP audit and inspection activities, and maintain a state of ongoing inspection readiness
- Mentor and manage staff, contractors, and/or consultants
- Ensure Albireo Clinical Study departments have annual GCP training.
Minimum Education, Experience, Knowledge and Skills Required:
- Bachelor’s degree required
- At least 6-8 years’ experience in Clinical Development and/or, Clinical Quality Assurance/Compliance function within the pharmaceutical/biotech industry
- Extensive knowledge of FDA / global clinical trial regulations and ICH E6(R2) GCP Guidelines
- Understanding of the clinical development process and documentation requirements
- Proactive approach to GCP compliance
- Knowledge of outsourced models of clinical research conduct and associated sponsor requirements
- Knowledge of site and vendor auditing processes and recent FDA and EMA compliance landscape
- Ability to work independently with minimal direction.