A global leader in the life sciences is looking or a new late phase QA manager. As the late phase SME, you will be responsible for generating, maintaining, and upholding phase-appropriate quality functions for pharmaceutical production including development, pre-clinical and clinical activities in a CRO/CDMO environment.
Key Responsibilities
- Exhibits technical depth in organizational management, cGMP (Good Manufacturing Practice) quality systems, US and non-US cGMP regulations and FDA, EU and ICH guidelines with practical implications and applications for a late phase clinical setting
- Able to architect and implement new phase appropriate cGMP systems (policy, procedures, work instructions etc.) to support late phase clinical offering
- Demonstrates record of successful interaction with regulatory agencies, internal and external auditing groups, and preparation of all required correspondence
- Demonstrates experience with clinical cGMP facilities, processing equipment, laboratory testing, manufacturing, and understanding of the technical, regulatory, development and commercial aspects of pharmaceutical products
- Develops staff in key quality systems and regulatory guidelines
- Escalates issues to the quality management and other Site leadership that could pose any compliance risks to the site
- Ensures R&D, product development and clinical procedures, equipment, facilities, people adequately meet regulatory requirements and are audit ready
- Provides guidance to the QA (Quality Assurance) team in the development, implementation and management of quality systems
- Approves Certificate of Compliance for late phase products
- Assures a steady flow of QA approval of late phase products
- Works with internal and external customers, US and non-US regulatory agencies and partners on quality and compliance issues
- Advises management on potential issues, and ensuring the implementation of the appropriate actions
Key Requirements
- Bachelor's degree
- Pharmaceutical/Biotechnology or related FDA (Federal Drug Administration) regulated industry experience is required
- Quality Assurance Management Experience required
- Experience with a CRO (contract research organization)/CDMO (contract development and manufacturing organization) or closely interacting with a CRO/CDMO preferred
- Prior cGMP experience and late Phase Product Development experience