Sr. Manager Quality Assurance [Switzerland]
Position Summary: The Senior Manager Quality Assurance is responsible for providing the quality oversight of routine GMP batch production activities at our Contract Service Provider (CSP) located in Switzerland. The Senior Manager Quality Assurance will have a strong scientific background/ education which will enable him/ her to be the point of contact for the day-to-day quality assurance activities for Apellis producing intermediates and drug substance. Furthermore the individual will support the process validation activities for the second generation drug substance (GEN2). Assures products conform to regulatory requirements, company standards, and satisfies GMP regulations. Work closely with global Quality organization and CSP partners to ensure quality events are thoroughly investigated, changes are assessed and implemented in a timely fashion and product meets Apellis' quality standards. The position includes review and approval of Quality Management System documentat...