Head (Director to Vice President) of Quality

Head (Director to Vice President) of Quality

About Foresee Pharmaceuticals

Please visit www.foreseepharma.com 

Job Description

Head of the Quality (at the Director to Vice President level depending on experience) has the overall responsibility of Quality operations in support of development and commercialization of all drug products and reports to the CEO of Foresee.  Concrete responsibilities include, for example,

• Build the Quality Unit and Quality function, help to set up Quality strategy and oversee all aspects of Quality operations
• Audit and qualify vendors and services providers for GxP activities and assure GxP compliance of vendors and services providers
• Conduct internal audit and assure GxP compliance of internal operations
• Lead and manage regulatory inspections
• Work with API and drug product manufacturers to review and release API and drug product
• Oversee and assure regulatory compliance of Foresee and its drug products and resolve any compliance issue
• Write, review and approve SOPs and conduct/oversee employee GxP training
• Review regulatory filings

Requirements

• B.S. degree in sciences with a minimum of 7 years of experience in the pharmaceutical industry and 5 years of experience in QA function
• Independent management of QA function, having experience in auditing and PAI, review and release of materials for human use, dealing with various compliance issues, review and approval of SOPs, etc.
• In-depth knowledge in GxP and regulations of human drug product and familiarity of ICH guidelines, FDA guidance to industry and EMA regulations
• Hands-on experience in and a proven track record of working effectively with internal and external teams on QA activities
• Ability of strategic thinking and working independently
• Effective oral and written communication

Application Instructions

To apply, please email your resume.