||Responsible for the oversight and management of the Quality Assurance activities related to NS Pharma’s Quality systems, including the oversight of CRO compliance, developing and executing system audit plans, providing regulatory guidance and support to study teams, supporting inspection readiness activities, etc.
|Essential Duties and
(Include but not limited to
Other duties may be assigned)
- Accountable for the management and oversight of the Company’s Quality Assurance activities including GxP.
- Oversees ongoing development and operation of the quality function and GxP quality management system.
- Directs the quality oversight of GLP, GCP, and GMP activities (including SOP development and maintenance, internal and external audit conduct, development and commercial stage batch release program) to ensure patient safety and data quality.
- Ensures the development and implementation of strategies to ensure compliance with applicable regulatory requirements.
- Ensures that a strategic audit plan is implemented for all products across all stages of development and commercialization, with timely and appropriate internal and external reporting and follow-up.
- Expected to proactively develop a comprehensive inspection readiness program. Represents the company, and may serve as, the primary inspection liaison during regulatory inspections.
- Provides strategic organizational direction to assure that responses to quality-related regulatory queries are timely and complete.
- Supports quality activities as needed during due-diligence efforts.
- Proactively advises senior management on developments in regulations and standards related to GXP quality that may impact company strategies and programs.
- Contributes to corporate quality- related goals and objectives.
- Provides key process indicators to support management review.
- Directs development and presentation of periodic reports describing compliance trends and identifying areas of potential risk to senior management.
- Responsible for the training and development of departmental staff, staff performance appraisals, recruitment and succession planning
- Perform other task as needed or required in managing the QA activities of the company.
- In depth knowledge in Clinical Audit processes
- Strong experience in GCP Quality Systems
- Strong knowledge in Global GCP regulations (US/EU etc.); ICHE6, 21 CFR Part 50, 54, 56, 312, 314, and high-level knowledge of 21 CFR Part 11 and International equivalents as necessary
- Experience in Investigation, Root Cause Analysis, CAPA and Effectiveness check processes, tools, and techniques
- Risk management principles and process, change management
- Phases 1-4 clinical trial within the drug development life cycle and regulatory requirements, best practices, industry standards
- Familiarity and understanding of multicultural environment.
- M.S. (or equivalent degree) and 15 + years of relevant work experience.
- Experience in the Pharma industry is required.