Remote position responsible for ensuring CMO’s remain compliant with regulations for the respective regions.
- Develop and Manage the Clinical Phase & Commercial Contractor Quality Management (CQM) Program for solid dosage, sterile and biologic dosage forms including preparation for external regulatory inspections.
- Develop and Manage the internal auditing program for External Operations, manage additional auditing personnel and perform vendor audits, and other qualification activities for Contracted Manufacturing, Packaging/Labeling, and Laboratory Organizations, Active Pharmaceutical Ingredient (API) vendors, key excipient vendors and early phase raw material vendors
BS Scientific discipline, 8 – 10 yrs experience in pharmaceutical / biotech manufacturing
Travel for position is 30 > 40% domestic only
Phone: 860-278-5840 ext 245