Quality Manager - Stability
Primary responsibilities may include:
• Supervise direct reports to complete external stability programs and projects
• Lead the development and implementation of program/process improvements
• External communication with contract laboratories to manage stability programs within regulations
• Participation in OOS/OOT investigations
• Use appropriate tools/systems to build efficient work practices
• Identify and provide training to staff and stakeholders
• Participate in regulatory audits - internal and external
This position will be responsible for the management of several temporary employees and several full time employees (currently 2 and 2). This position will be responsible for more than 200 products that are handled at external laboratories. The budget for this function is in excess of $2.5MM. The person in this role will be expected to drive consistent practices and provide plans for consolidation and cost savings.
Minimum Bachelor’s Degree in scientific or engineering discipline, graduate degree a plus. Strong background in analytical chemistry. Knowledge of stability and regulatory practices surrounding stability results necessary. Experience working in a changing environment and fast-paced organization as a member of cross-functional teams. Experience in project management a plus. Understanding of Contract Research Organization (CRO) practices, a plus. LIMSexperience would be of benefit.
Minimum of 8years in Medical Device or Pharmaceutical Industry, ideally in R&D Product Development, Analytical Chemistry Laboratory, and/or Quality.