.With a clinical-stage biopharmaceutical company focused on the development of advanced therapies for the treatment of liver and cardio-metabolic diseases. THE ROLE The Senior Director of Clinical Quality Assurance reports directly to the Vice President of Quality and plays a crucial role in collaborating with Clinical Operations to integrate quality and compliance into both long-term strategies and daily operations. This position is pivotal in the establishment, enhancement, and upkeep of quality systems. Additionally, it involves spearheading functional and cross-functional projects aimed at instilling continuous improvement principles throughout the entire company. The scope of responsibilities closely collaborate with various departments, including Clinical Operations, Clinical Development, CMC, Medical Affairs, Regulatory Affairs, CROs, CDMOs, Clinical Trial Sites, and laboratories. As the role evolves, there may be future leadership responsibilities, potentially involving team expansion, and occasional travel may be required.
Establish and maintain GCP QA programs, policies, and procedures and ensure cGCP compliance of clinical trials.
Serve as the main liaison with internal departments, including Clinical Operations and Clinical Development, fostering a collaborative business partnership.
Act as the principal point of contact for vendors, contract facilities, and service providers, overseeing the quality aspects of clinical trials.
Manage and supervise the auditing and qualification processes for clinical trial vendors, suppliers, and contracted organizations and facilities.
Ensure adherence to relevant health authority regulations and guidelines concerning document management, Trial Master File (TMF), and software utilized in Good Clinical Practice (GCP) processes.
Take responsibility for drafting and maintaining Standard Operating Procedures (SOPs) for Good Clinical Practice, providing associated training as needed.
Interpret and comprehend policies and guidance from global regulatory agencies, ensuring alignment with internal policies and procedures at 89bio.
Be accountable for Quality Assurance review of clinical trial documentation and documents submitted to regulatory agencies.
Manage inspection readiness concerning GCP and act as the primary liaison with Health Authorities and Partners during internal audits and Health Authority inspections.
Conduct audits at Clinical Trial Sites and Contract Research Organizations to verify the compliant conduct of clinical trials.
Monitor and address current and anticipated quality issues, escalating significant concerns to management as necessary.
Bachelor's degree in a scientific discipline (e.g., biology, chemistry, pharmacy).
Minimum of 12 years of biotechnology experience with 3+ years in an applicable Sr. Quality leadership role.
8 years minimum of GCP Quality Assurance experience.
Solid track record of compliance and successful audits, developing compliant SOPs and practices.
Developed and maintained QA systems.
Worked with CROs.
Knowledgeable on drug development process, global regulations, and interfacing related to GXP and GCP.
Successful collaboration and open and authentic communication in a diverse workplace; record of strong partnerships with clinical development/operations.
Strong written and oral communication skills, strong skills in translating complex concepts across all levels of the organization.
Ability to work independently in a fast-moving start up environment.
Meet Recruitment 2022. Meet Recruitment Ltd., Meet Recruitment Inc. and Meet Personalberatung GmbH are all subsidiaries of Meet Group (No. 13556131) a company registered in England and Wales at Irongate House, 22-30 Dukes Place, London, EC3A 7LP.