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Senior Director Quality Assurance
|Location||US-PA-King of Prussia|
|How to Apply|
Support senior quality leadership to build up and maintain a global quality and compliance program;
Support senior quality leadership to align the global quality system across the Company;
Lead and conduct internal audits across the Company as well as vendor audits for the Company as needed;
Host and facilitate external audits by clients and/or regulatory agencies and follow-up CAPAs;
Provide readiness support for inspections by international regulatory authorities at designated Company sites;
Act as a QA representative on CMC projects and communicate with clients about quality issues and provide routine updates;
Provide general and advanced GMP trainings to quality and technical staff;
Recruit QA talent to build up a strong quality team and quality management system at designated Company sites;
Lead quality related assignments as directed by management.
Advanced degree in engineering, biology, chemistry, or related field.
10+ years relevant work experience.
SME of global standards in GMP, compliance, regulatory applications (IND to BLA).
Late stage biologic product development and commercialization expertise are highly desirable.
Effective management of projects and staff, cross-departmental collaborations are expected.
Outstanding communication and language skills.