Provide leadership and manage the activities of Quality Assurance (QA) Quality System Engineering (QSE), including change control, management of qualification and validation activities, deviation/complaint/OOS/return/recall.
(1) Scientific discipline preferred.
(2) At least 5 years’ experience in QA for a regulated industry, pharmaceutical (API and/or drug product) experience. Minimum 3 years in management. Ability and experience in development and leadership of staff.
(3) Thorough, in-depth knowledge of GMPs and related regulatory guidelines. Strong prioritization and organization skills. Excellent verbal and written communication skills, fluent in English preferred.