Summary of Position:
We are seeking a QA Manager (Contractor) to assist with various quality assurance administrative matters. This is a full-time temporary position for approximately 12 months. This individual will have responsibility for management of the Clinical Quality Systems training, SOP and other controlled document development, quality metrics tracking and reporting. The position may need interaction with Clinical Operations to provide Clinical Study support related to GCP QA. The successful candidate will have knowledge of Quality Management System. A minimum of two years’ experience in the QA department of a biopharmaceutical company and/or a CRO.
Job Title: Quality Assurance Manager
Reports to: Senior Director, Quality Assurance
Employment Type: Full-Time, Temporary (Contractor – Fully Remote)
Key Essential Functions:
- Manage and track training SOPs and GCP related training in electronic Quality Management System
- 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.
- 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.
- 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.
- Maintain quality agreements with contract service providers/vendors
- Position may require occasional travel.
Required Skills Qualifications:
- Bachelor’s degree with at least 2 years’ experience in the biopharmaceutical industry or a CRO in Clinical Quality Assurance
- Knowledge of Good Clinical Practice, 21 CFR Part 11, ICH guidelines and FDA regulations
- Technical writing skills
- Excellent oral and written communication skills
- Excellent organization skills with ability to prioritize tasks
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 a clinical-stage oncology company developing transformative, targeted therapeutics to treat life-threatening cancers. The company is based in Houston, Texas, and has a satellite office in the Research Triangle Park area in NC. For more information, please visit our website at https://aravive.com.
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