• US Shift 
• Working Days: 5 days (Mon-Fri)
• Experience: 5+ years

Job Roles and Responsibilities:

• Management of all QA requirements of our CMOs
• Liaise with subject matter experts to ensure the organization’s compliance with applicable GMP regulations.
• Manage the QA aspects of a network of suppliers and co-development partners to ensure compliance and project progress at required quality.
• Build and maintain the CMO quality system and related processes and provide strategic expertise to leadership and project teams on CMO and GMP matters.
• Perform quality assurance activities (such as validation protocol/report review and approval, specification review and approval, batch record review and release, etc.) to ensure timely delivery of finished (packaged and labeled) product.
• Follow established quality systems procedures required for appropriate GMP compliance including change control, deviations, complaints, training, etc.
• Ensure supporting product, supplier and quality systems documentation is maintained in accordance with company and industry standards.

Ideal candidates will have:

• Degree in the life sciences or equivalent qualification, with 5+ years of QA experience
• Strong knowledge of cGMP at a pharmaceutical or medical device organization
• Strong knowledge of US FDA regulation such as 21 CFR, 210, 211, 820 and other regulatory standards
• Strong understanding of CMO management and underlying processes
• Thorough knowledge of global GMP requirements for all phases of product development through commercialization; pharmaceutical development/manufacturing
• Experience in planning and conducting internal and external audits and regulatory agency inspections and negotiating and implementing quality agreements.
• Ability to work both independently and as part of a team.
• Working knowledge of technical, analytical aspects, and validation as applied to pharmaceutical manufacturing, testing and equipment.
• Fluency in English