https://careers-wuxiapptec.icims.com/jobs/5700/senior-director-quality-assurance/job?mode=view

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.