This role provides GMP quality oversight for products in development at external suppliers in North America for Bausch Health. The role will manage product development lifecycle and provide input to quality deliverables through to commercialization and assure successful transition to the commercial quality group.
Support the development of new portfolio products in the pharmaceutical and medical device space by:
-Ensuring activities of the team are meeting current expectations with standards relevant to GMP work according to the phase of work being completed.
- Support the development of appropriate risk-based strategies and responses to any observations involving this function.
- Participate in inspection readiness activities for all projects that are within your scope to assure successful registration/approval (e.g. PAI).
Scope of Position:
The position will be responsible for North American product development in both the pharma and the medical device spaces. The position will report to the Manager, R&D Quality, EMQA.
B.S. degree in technical field, minimum of 5 years' experience in pharmaceutical field required. Previous experience in a quality role preferred.