This role provides GMP quality oversight for products in development at external suppliers in North America for Bausch Health. The role will lead the development of compliance practices related to full lifecycle management practices for new development projects and assure successful transition to the commercial quality group.
Lead the Development GMP quality organization and program including the following duties:
-Ensure practices are current with standards relevant to GMP work by developing phase appropriate processes and implementing practices for regular review of the regulatory space.
- Develop a staffing strategy that appropriately utilizes internal and consultant resources to meet project timelines.
- Support the development of appropriate risk-based strategies and responses to any observations involving this function.
- Develop inspection readiness strategies and programs to assure successful registration/approval (e.g. PAI).
-Establish goals and objectives for the teams focusing on skill and career development in line with business needs.
- Assure appropriate training of all staff members.
- Plan and manage appropriate department budgets.
- Maintain alignment with partner organizations to drive for open communication and shared processes.
Scope of Position:
The position will be responsible for the North American product development in both the pharma and the medical device space. It is expected to be a team of 4-11 people with budgetary oversight as well. The position will report to the Sr. Director of Quality Technical Support, EMQA.
B.S. degree in science field, plus 10 years' experience in pharmaceutical field required. Master Degree in science field preferred. Previous experience in quality required.