Director, Clinical Quality Assurance

Overview

Position
:
Director, Clinical Quality Assurance
Department
:
Global Clinical Development
Location
:
Remote (PST Zone) with up to 25% global and domestic travel
Reports 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 Quality Assurance (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.

• 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.

• 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 MS Word, PowerPoint, Excel, and others.
• Able to travel domestically and internationally up to 25% of the time.

• 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
• Paid Sick Leave
• Telecommunication Monthly…