Late Phase Quality Assurance Manager
A leading pharmaceutical & biotechnology company has an opening for a late phase quality assurance manager at its Bend, OR site. As a late phase quality assurance manager, you will be responsible for building, maintaining and sustaining phase-appropriate key quality functions for late phase pharmaceutical production including development, pre-clinical and clinical activities in a CRO/CDMO environment.
Key Duties
- Exhibits technical depth in organizational management, cGMP quality systems, US and non-US cGMP regulations and FDA/EU/ICH guidelines with practical implications and applications for a late phase clinical setting
- Able to design 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
- Trains 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 team in the development, implementation, and management of quality systems
- Approves Certificate of Compliance for all 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 & compliance issues
- Advises management on any potential issues, and ensures the execution of the appropriate actions
Key Qualifications
- Bachelor's degree, preferably in the sciences (Chemistry, Biology, etc.)
- Pharmaceutical/Biotechnology or related FDA-regulated industry experience required
- Quality Assurance management experience required
- Experience with a CRO/CDMO preferred
- Prior cGMP experience and late phase product development experience
