Summary of Position: The successful candidate will be actively involved in helping build the Quality Assurance (QA) systems at Aravive. This individual will have the responsibility for establishing, implementation and management of the quality systems with the primary focus of Electronic Quality Management Systems (EQMS), training, auditing, vendor qualification, quality metrics tracking and reporting. The position will also include working with cross-functional teams to support regulatory filing activities. 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, Quality Systems
Reports to: Senior Director, Quality Assurance
Employment Type: Full-Time
FLSA Status: Exempt
Date: Fall 2020
- 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 GXP training program and provide training as required including the annual GCP training.
- Manage and maintain the vendor qualification program and GXP contract service provider audits.
- Maintain quality agreements with contract service providers/vendors
- Oversee the deviation, CAPA, change control, investigation and non-conformance programs to ensure compliance with internal SOP and regulatory authority requirements.
- Develop, track and trend quality metrics.
- Interact with clinical and regulatory departments in support of Regulatory Submission activities.
- Participate in the review of regulatory submission documents.
- May perform internal and external audits.
- Collaborate with cross functional teams on FDA and other regulatory authority inspections, including inspection preparation, hosting and responding to observations.
- 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 within technical operation, manufacturing and/or QA functions.
- Prior experience in implementation and management of Quality Management System is required.
- Experience with biological products in Oncology preferred
- Strong technical writing skills.
- Strong knowledge of cGMP/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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