Senior Quality Assurance Specialist, PPQ/Commercial QA Projects

Job description

About this opportunity: The Senior QA Specialist is responsible for interfacing with and provide quality input to client’s manufacturing programs that are in late stages of development and/or commercialized. This includes interfacing with clients that are nearing process performance qualification (PPQ), PAI and commercial readiness, and that are approved to manufacture in global regions. Key Responsibilities: - Provide leadership to any direct reports that manage client manufacturing programs at Avecia. - Act as QA project representative along with department management on Client Manufacturing campaigns and at client meetings (e.g., onsite and teleconferences) as directed by QA Project Team management. - Prepare responses to customer supplied QA agenda topics and lead discussions during client meetings ensuring that any outstanding questions relative to the agenda topics are discussed with QA department management. - Provide strong link/communication between the QA function/activities with all other departments at the Milford site. - Support the Customer QA SME along with department management in support of Avecia’s Audit hosts during Regulatory or Client audits. - Support the revi...