Summary of Position:
The successful candidate will be actively involved in helping build the Clinical Quality Assurance (QA) systems at Aravive. This individual will have the responsibility for GCP Auditing in addition to establishing, implementation and management of the Clinical Quality Systems training, vendor qualification, quality metrics tracking and reporting. The position will also include working closely with Clinical Operations to provide Clinical Study support related to GCP QA. The successful candidate will have a thorough knowledge of Quality Management System, associated regulations, and experience in the QA department of a biopharmaceutical company. Aravive is a fast-paced, small organization and the ability to be productive and successful in an intense and collaborative work environment is critical.
Job Title: Associate Director, Clinical Quality Assurance
Reports to: Senior Director, Quality Assurance
Employment Type: Full-Time
FLSA Status: Exempt
Date: Winter 2020
- Lead development of trial oversight plans and periodic reviews of risk; communicate/report risks and issues to the Senior Management
- Participate on clinical study teams and support development of clinical documents and systems in compliance with GCP, regulatory requirements and internal policies/SOPs
- Develop and execute annual GCP audit plans
- Provide guidance during development and execution of Corrective and Preventive Actions (CAPAs) for GCP and PV audits.
- Assess and manage significant issues as they arise and manage risks to quality at a study level
- Identify improvements that support quality, compliance with regulations and company standards; policies and procedures through partnership with internal and external stakeholders; Development Line Functions and QA groups.
- Provide interpretation of GCP regulations and company process standards, guidelines, policies and procedures to relevant personnel.
- Manage the implementation of the electronic quality management system (EQMS).
- Develop and maintain Standard Operation Procedures (SOPs) Policies, Job-Aids and other related documents.
- Implement improvements to existing GXP Standard Operation Procedures (SOPs)
- Manage the GCP training program and provide training as required including the annual GCP training.
- Manage and maintain the vendor qualification program and GCP contract service provider audits.
- Maintain quality agreements with contract service providers/vendors
- Position may require occasional travel.
Required Skills Qualifications:
- Bachelor’s degree with at least 10 years or Master’s degree in scientific discipline with at least 8 years experience is required in the biopharmaceutical industry in Clinical Quality Assurance
- Experience with Oncology is a plus
- Strong knowledge of Good Clinical Practice, 21 CFR Part 11, ICH guidelines and FDA regulations
- Strong technical writing skills.
- Strong knowledge of cGCP requirements including ICH guidelines and specific regulatory authority requirements (FDA, EMA, PMDA, etc.).
- Excellent oral and written communication skills.
- Excellent organization skills with ability to prioritize tasks.
- Medical, Dental, Vision, 401(k)
Aravive, Inc. is an Affirmative Action/Equal Opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, protected veteran status, national origin, disability, sexual orientation, gender identity, marital status, genetic information or any other characteristic protected by law.
Company Overview: Aravive, Inc. is developing treatments designed to halt progression of life-threatening diseases, including cancer and fibrosis. Our approach draws on novel insights into targeting signaling pathways that drive the activation, migration and invasion of abnormal cells into healthy tissues. The company is based in Houston, Texas, and received support from the Cancer Prevention & Research Institute of Texas (CPRIT). For more information, please visit our website at https://aravive.wpengine.com.
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