Director, Clinical Quality Assurance

Position Director, Clinical Quality AssuranceGlobal Clinical DevelopmentRemote (PST Zone) with up to 25% global and domestic travelReports To: VP, Head of Global Clinical Operations Position Summary The Director of Clinical Quality Assurance will be responsible for ensuring quality and compliance of Angitia sponsored clinical studies with respect to Standard Operating Procedures, applicable regulatory requirements (FDA, ICH, other country specific requirements) as well as supporting the non-clinical team on ensuring GLP studies are conducted compliantly. This role will work closely with the Heads of QA, Clinical Operations and Translational Sciences. This position reports to the VP, Head of Global Clinical Operations but may transition to Quality Assurance as that group grows. Responsibilities Drive and cultivate a culture of quality throughout the company to help ensure compliance with all applicable regulations, guidelines, and corporate standards, policies, and procedures. Provide QA oversight and support to internal staff in support of Angitia sponsored clinical studies and GLP studies. Development and management of processes and controlled documents related to Angitia sponsored clinical studies (clinical operations, clinical development, pharmacovigilance, regulatory) and GLP studies (translational medicine). Prepare for health authority audit readiness. Develop phase-appropriate Clinical QA operating models in accordance with ICH risk-based compliance guidance; set a strong foundation for future commercial operations. Develop and implement audit plans and schedule for clinical study vendors and other study related GxP vendors (CROs, central /specialty labs, imaging, etc.). Oversee and/or perform site and vendor audits to assure quality assurance compliance with regards to all internal as well as applicable regulatory guidelines. Lead selection of contract auditors to perform site and vendor audits as needed. Ensure timely and effective follow up to all identified or assigned quality issues. Conduct QA review of Angitia sponsored clinical study documents, internal controlled documents and vendor documents. Train internal staff on regulatory requirements such as GCP training. Ensure training compliance and completion for Clinical Development, and potentially others. Identify critical compliance and/or business issues related to GxP, CROs, Contract Test Laboratories and manufacturers of critical starting materials. Create and execute remediation strategies and tactical plans as needed using a risk-based approach. Develop and oversee study quality metrics for clinical studies including study risk assessment, mitigation and CAPA management. Coordinate and host all FDA and Health Authority inspections. Ensure all Quality agreements are effectively negotiated to meet the near- and long-term needs of Angitia as agreed with legal, finance and functional heads. May require up to 25% travel. Qualifications BS BA (or equivalent) in a relevant scientific discipline; advanced degree desirable. 10+ years of Biotechnology industry with at least 8-12 years' experience in Quality Assurance, or equivalent levels of education and / or experience. Strong knowledge of GCP, GLP, and ICH clinical study requirements. Experience with both domestic and international clinical studies (CDE, EMA and FDA regulations). Experience building a quality program and quality system in young, science-driven organizations. Experience leading audits of GXP vendors as well as clinical sites. Demonstrated problem-solving and critical thinking skills. Excellent interpersonal, written and verbal communication skills. Excellent computer skills in the following programs: MS Word, PowerPoint, Excel. And others. Able to travel domestically and internationally up to 25% of the time. About Angitia Established in June 2018, Angitia Biopharmaceuticals is a clinical-stage biotechnology company focused on the discovery and development of innovative therapeutics for serious musculoskeletal diseases. Angitia is currently studying 3 biologic product candidates in the clinic for the treatment of osteoporosis, osteogenesis imperfecta (OI), and spinal fusion. Leveraging the team's extensive experience and scientific acumen in novel drug development, Angitia is committed to providing groundbreaking therapies to satisfy key unmet medical needs. The founder and the core team members of Angitia are seasoned scientific leaders in new drug discovery, development, and management from both overseas and domestic large multinational companies. The company has built an organization with offices in Westlake Village, CA and Guangzhou, China that is distinguished by world-class scientists with talents that are proficient in the pathophysiology of musculoskeletal diseases. We utilize cutting-edge technologies of genetics and molecular biology to uncover new mechanisms, signal transduction pathways and their interactions combined with computer aided drug design to identify new drug targets, and to discover and develop new biological and small molecule medicines. The company is committed to serving patients in need by carrying out innovative science including internal research and external collaborations with academics and global biopharmaceutical companies. We are seeking talented individuals who are innovative, ambitious, and great team players to join our vibrant group. Benefits Medical, dental, and vision coverage for employees and their eligible dependents 401(K) Retirement Plan with Company match Company paid Long Term Disability Coverage Company-paid life Insurance & AD&D Coverage Voluntary Life Insurance & AD&D Coverage Employee Assistance Program (EAP) Company-paid Holidays Vacation Telecommunication Monthly Stipend Work-From-Home Equipment Reimbursement Equal Employment Opportunity As set forth in Angitia Incorporated Limited’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law. #J-18808-Ljbffr