Senior Director Quality Assurance

Company:   WuXi Biologics
Location:  US
Posted:  2019-09-15

Job ID:2019-5700 Responsibilities  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. Qualifications  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.

How to apply

 Application Link: assurance/job?mode=view  Please feel free to contact or +1 609-703-3769 if you have any questions.